Femtosecond-Lasik Risks, Complications and Problems

Helicopter pilot suffers melting of the cornea after bladeless LASIK

Bucci MG, McCormick GJ. . Idiopathic peripheral necrotizing keratitis after femtosecond laser in situ keratomileusis. J Cataract Refract Surg. 2012 Jan 19.

From the full text: In April 2010, a 31-year-old helicopter pilot presented to our clinic for LASIK evaluation... The Femto LDV laser was used for flap creation, and a Customvue laser ablation was performed with the Visx Star S4IR excimer laser (Abbott Medical Optics, Inc.)... The next day (postoperative day 3), the patient returned to the clinic reporting "stinging" in his right eye. Slitlamp examination revealed progressively worsening corneal infiltration with stromal necrosis in several areas at the flap margin... The inflammation resulted in flap margin necrosis and a scalloped flap edge in both eyes.

Link to abstract

IntraLase Femtosecond Laser vs Mechanical Microkeratomes in LASIK for Myopia:
A Systematic Review and Meta-analysis.

J Refract Surg. 2012 Jan;28(1):15-24. doi: 10.3928/1081597X-20111228-02.
Chen S, Feng Y, Stojanovic A, Jankov MR 2nd, Wang Q.

Abstract

PURPOSE: To evaluate the safety, efficacy, and predictability of IntraLase (Abbott Medical Optics) femtosecond laser-assisted compared to microkeratome-assisted myopic LASIK.

METHODS: A comprehensive literature search of Cochrane Library, PubMed, and EMBASE was conducted to identify relevant trials comparing LASIK with IntraLase femtosecond laser to LASIK with microkeratomes for the correction of myopia. Meta-analyses were performed on the primary outcomes (loss of ≥2 lines of corrected distance visual acuity [CDVA], uncorrected distance visual acuity [UDVA] 20/20 or better, manifest refraction spherical equivalent [MRSE] within ±0.50 diopters [D], final refractive SE, and astigmatism), and secondary outcomes (flap thickness predictability, changes in higher order aberrations [HOAs], and complications).

RESULTS: Fifteen articles describing a total of 3679 eyes were identified. No significant differences were identified between the two groups in regards to a loss of ≥2 lines of CDVA (P=.44), patients achieving UDVA 20/20 or better (P=.24), final UDVA (P=.12), final mean refractive SE (P=.74), final astigmatism (P=.27), or changes in HOAs. The IntraLase group had more patients who were within ±0.50 D of target refraction (P=.05) compared to the microkeratome group, and flap thickness was more predictable in the IntraLase group (P<.0001). The microkeratome group had more epithelial defects (P=.04), whereas the IntraLase group had more cases of diffuse lamellar keratitis (P=.01).

CONCLUSIONS: According to the available data, LASIK with the IntraLase femtosecond laser offers no significant benefits over LASIK with microkeratomes in regards to safety and efficacy, but has potential advantages in predictability.

Rainbow Glare - A potential complication of femtosecond-Lasik

From the article: Patients affected by rainbow glare describe seeing a spectrum of colored bands proceeding in rainbow-like fashion. The effect is most prominent in the dark when looking at pinpoint light sources, such as oncoming automobile headlights at night...

In rainbow glare cases, patients describe sharp colored radiating symmetrical halos extending laterally and vertically around bright light sources, from which they are separated by a free interval. These disturbances are usually seen with one eye only : in most of the reported cases, rainbow glare is unilateral or much more pronounced in one eye than in the other one.

Link to article

Keratectasia following LASIK in a patient with uncomplicated PRK in the fellow eye.

J Cataract Refract Surg. 2011 Mar;37(3):603-7.
Hodge C, Lawless M, Sutton G.

Abstract: We present a case of unilateral keratectasia in a laser refractive surgery patient. Laser in situ keratomileusis (LASIK) was performed in the first eye, but because of difficulty lifting the femtosecond-created cap in the second eye, photorefractive keratectomy was performed in that eye. Neither eye had risk factors for keratectasia; both had identical low scores on the Randleman risk factor score. Although femtosecond laser caps were created in both eyes, ectasia developed in only the LASIK eye, in which the cap was lifted. We believe this is the first case of this complication reported in the literature. It highlights our incomplete knowledge of the risk factors for keratectasia following LASIK and suggests that unlifted flaps do not undergo the same biomechanical weakening as flaps that are lifted.

Latest reported incidence of DLK with IntraLase (bladeless) LASIK - November, 2010

Incidence of diffuse lamellar keratitis after LASIK with 15 KHz, 30 KHz, and 60 KHz femtosecond laser flap creation.
J Cataract Refract Surg. 2010 Nov;36(11):1912-8.
Choe CH, Guss C, Musch DC, Niziol LM, Shtein RM.

From the Department of Ophthalmology and Visual Sciences (Choe, Musch, Niziol, Shtein), the Medical School (Guss), and the Department of Epidemiology (Musch), University of Michigan, Ann Arbor, Michigan, USA.
Abstract

PURPOSE: To compare the incidence of diffuse lamellar keratitis (DLK) after laser in situ keratomileusis (LASIK) with flap creation using the 15 kHz (FS15), 30 kHz (FS30), or 60 kHz (FS60) femtosecond laser.

SETTING: University-based academic practice, Ann Arbor, Michigan, USA.

DESIGN: Retrospective comparative case series.

METHODS: Consecutive myopic LASIK cases performed between January 1, 2005, and June 1, 2007, using the IntraLase FS15, FS30, or FS60 femtosecond laser for flap creation were reviewed. Preoperative clinical characteristics, treatment parameters, and intraoperative and postoperative complications were recorded. Statistical comparisons were made using repeated measures analysis, analysis of variance, chi-square, and Fisher exact tests.

RESULTS: Five hundred twenty eyes of 274 patients were included in the study. One hundred seventy-six eyes (93 patients) were treated with the FS15 laser, 180 eyes (93 patients) with the FS30 laser, and 164 eyes (89 patients) with the FS60 laser. Seventeen eyes (10%) in the FS15 laser group, 24 eyes (13%) in the FS30 laser group, and 23 eyes (14%) in the FS60 laser group developed DLK. There was no statistically significant difference in the incidence of DLK between the 3 groups (P = .68).

CONCLUSION: There was no significant difference in the incidence of DLK between the FS15, FS30, and FS60 groups.

Group asks for recall of "all-laser LASIK" devices - Reprinted with permission www.fdaweb.com 10/15/2009

From the article: LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists and physicians to Rep. John Dingell (D-MI) on abuse of the 510(k) program by clearing devices that were never evaluated for safety and effectiveness.

Link to article

Bladeless LASIK devices (IntraLase, FemTec, Da Vinci) cleared by FDA without clinical trials.
LasikNewswire 5/15/2009

From the article: In the ophthalmic lasers example, injured LASIK patients circulated on the Internet a Journal of Cataract & Refractive Surgery editorial by William J. Dupps, Jr. that commented on a University of Toronto clinical study of 149 eyes treated with a 15kHz Intralase femtosecond laser in which 56% were associated with an adverse event called opaque bubble layer (OBL). New-generation lasers with higher pulse frequencies may be less likely to cause OBL, Dupps said. All these devices entered the market through 510(k) clearances.

Link to article

Patient damaged by latest custom bladeless technology testifies at April, 2008 FDA hearing.

The New York Times: "Matt Kotsovolos worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, and said doctors classified him as a success because he now has 20-20 vision — something Mr. Kotsovolos charged was a deceptive industry practice. “For the last two years I have suffered debilitating and unremitting eye pain,” Mr. Kotsovolos said."  Link to article

The LASIK industry markets this technology under a variety of names and descriptions. Here are a few: IntraLase, IntraLASIK, femtosecond LASIK, blade-free LASIK, all-laser LASIK, bladeless LASIK, and iLASIK when combined with VISX custom LASIK.

Some of the reported complications of femtosecond lasers are opaque bubble layer, corrugated corneal stromal bed, extreme light sensitivity, partial flaps, rainbow glare, torn flap, vertical gas breakthrough, epithelial ingrowth, flap necrosis, diffuse lamellar keratitis (DLK), corneal perforation, incomplete flap, decentered flaps, small flaps, slipped flaps, flap folds, traumatic flap dislocation, gas bubbles in the anterior chamber, optic nerve damage, flap tears, haze, macular hemorrhage, infection, stromal cell necrosis, inflammation, keratocyte cell death, corneal nerve damage, goblet cell reduction, and interface particles.

Read more about the side effects, risks, complications, and problems of bladeless LASIK: Link

Femtosecond-Lasik injuries reported to the FDA

The following are adverse events associated with femtosecond LASIK reported to the FDA. You may search the FDA database for injuries related to femtosecond lasers using product code OOE or HNO, or enter a brand name.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1828643

Event Date 05/01/2010. Had custom Intralase LASIK performed on both eyes in May. Since have had severe dry eye, halos, floaters, starbursts, and light sensitivity. I wore contacts for years and my eyes never bothered me before. Now I am in constant pain. I have never had depression before and since LASIK have fallen into a deep depression. My physician downplayed the side effects saying they were uncommon, occuring less than 1% of the time, with the newer lasers and if I had custom LASIK, the change of side effects would be even less.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1843552

Bilateral Intralase LASIK performed in [redacted] 2010, using the VISX CustomVue system. Pre surgery prescription OD -3. 14 ds -0. 32dc, OS -3. 12ds -0. 66dc. Prior to surgery, no dry eye conditions, excellent corrected low light vision, no appearance of floaters, no history of chronic headaches, no history of suicidal thoughts. Three months post surgery complications - pain in the right eye accompanied by headaches, dry eyes, appearance of many dark floaters, starbursts and halos around bright light sources -in both low and moderate lighting conditions-, reduced contrast sensitivity - reduced ability to see well in low lighting-, induced astigmatism. These conditions result in reduced ability to drive at night, reduced ability to concentrate while on the job, reduced ability to participate in activities and everyday tasks in low light settings; increased sensitivity to bright light, increased depression, increased anxiety.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1252365

Since having intralasik eye surgery, i have developed posterior vitreous detachment or severe floaters. I have also suffered from dry eye as well as eye strain. The suction cup used in the lasik procedure sucks out vitreous opacities from the back of the eye leading to the appearance of floaters. Lasik doctors do not inform their clients on the possible dangers that the suction cup may have on the structure of the eye or creation of floaters. Lasik doctors also misinform their clients by telling them that nerve regeneration will occur after nerve severing is initiated. The truth of course is that there are no recorded scientific evidence that nerve regeneration fully occurs. In fact, 5 year studies from school of ophthalmology find that nerve regeneration reaches only 80 percent of preoperative levels. Five years, imagine eye doctors telling their patients that it may take as long as five years for their cornea nerves to regenerate 80 percent, that is, if they do at all, there is of course no guarantee. It is no wonder that dry eyes is the most prevalent side effect after lasik, doctors simply distort the facts to advance their cause. The fda has completely dropped the ball when it comes to holding the lasik industry accountable for medical malpractice. There is ample data from credible doctors and universities that substantiate my claim that lasik is harmful to the eye, and that doctors knowingly mislead the patient in the hope to secure his or her business. The facts are simple, lasik creates dry eye, floaters, compromises the integrity of the eye, and in many cases creates psychological cases of depression, hopelessness and disillusionment toward humanity and its supposed hippocratic moral keepers. The fda and its lobbyists are just as complacent in this farce as are its executioners. In fact, one could say the fda, as supposed guardians of the people, are even more at fault for allowing such a "abject" procedure to manifest itself. Evil permitted is sometimes worse then evil committed. Its time for the fda to redeem itself and put an end to lasik surgery once and for all, or at the very least force doctors to be as a honest and forthcoming about the potential side effects of lasik as i am now. Wishful thinking.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1229645

The intralase fs laser was used to create a corneal flap for lasik surgery in 2008. During the procedure, opaque bubble layer (obl) occurred in the superior region near the hinge, which resulted in a sticky lift. One day post-operatively in thenext day, the patient presented with stage 2-3 diffuse lamellar keratitis (dlk). A flap lift and rinse was performed. Patient was treated with topical and oral steroids.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1056867

Model Number INTRALASE
I had lasik surgery about a year ago and now i'm experiencing "starburts" and glare at night. I had the surgery done by a very well recommended surgeon, so i didn't 'cheap it off'. The starbursts are getting worse and worse but seems to go away a little when i use lubricating drops. Please stop people from having the surgery done until they've worked all the "kinks" out of it. People are having their vision damaged. Dates of use: 2007 - 2008. Diagnosis or reason for use: terrible vision. [Redacted] F: lasik surgery requires that the patient take too much responsibility for their healing. Please stop this procedure until it can be perfected!.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=437618

THE INTRALASE FS LASER WAS USED TO CREATE A CORNEAL FLAP FOR BILATERAL MONOVISION LASIK SURGERY. THE FLAPS ON BOTH EYES WERE CREATED SUCCESSFULLY. AFTER THE FLAP WAS CREATED ON THE SECOND (LEFT) EYE, THE SUCTION WAS RELEASED AND THE SUCTION RING ASSEMBLY WAS REMOVED FROM THE EYE. THE BEAM DELIVERY DEVICE (BDD) WAS LIFTED OFF THE EYE WHILE THE SURGEON REPLACED THE CORNEAL FLAP. WHILE THE BDD WAS MOVING UPWARDS, DOWNWARD MOTION WAS INADVERTENTLY INITIATED. THE SURGEON AND ASSISTING SURGEON ATTEMPTED TO REVERSE DIRECTION OF THE BDD USING THE JOYSTICK, HOWEVER THE JOYSTICK BROKE OFF OF THE UNIT AS A RESULT OF EXCESSIVE FORCE. THE BDD DID NOT CONTACT THE EYE, BUT DID MAKE CONTACT WITH THE PT'S LEFT TEMPORAL PERIORBITAL AREA. THERE WAS NO VISIBLE OR DISCERNABLE INJURY TO THE PT, I.E., LESIONS OR CONTUSIONS; HOWEVER, AT THE 10-DAY POST-OPERATIVE VISIT, MILD YELLOWING IN THE AREA WAS NOTED BY THE SURGEON, INDICATING THAT BRUISING HAD OCCURRED. NO CONTACT WAS MADE WITH THE EYE, AND THE PT'S UNCORRECTED VISUAL ACUITY IMPROVED FROM 20/400 PRE-OPERATIVELY TO 20/70 ON THE FIRST DAY OF POST-OPERATIVE.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=428421

THE JOYSTICK OF THE INTRALASE FS LASER WAS NOT WORKING PROPERLY. THE JOYSTICK, WHICH CONTROLS MOVEMENT OF THE DELIVERY SYSTEM, MOVED IN THE OPPOSITE DIRECTION. SPECIFICALLY, WHEN DOWNWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED UP; AND WHEN UPWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED DOWN. THIS MALFUNCTION WAS DETECTED PRIOR TO SURGERY, THERE WAS NO PATIENT INVOLVEMENT OR INJURY. UPWARD MOVEMENT DOES NOT POSE ANY PATIENT RISK, HOWEVER UNANTICIPATED DOWNWARD MOVEMENT OF THE DELIVERY SYSTEM HAS THE POTENTIAL TO CAUSE CORNEAL TRAUMA.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=427562

DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP AND THE INTRALASE FS DISPOSABLE PATIENT INTERFACE (PI) WAS USED TO APPLANATE THE CORNEA PRIOR TO FLAP CREATION. DURING FLAP CREATION, THERE WAS A SMALL AREA OF INEFFECTIVE PHOTODISRUPTION THAT REQUIRED ADDITIONAL MANIPULATION TO LIFT THE FLAP. THIS EVENT DID NOT RESULT IN ANY PATIENT INJURY AND THE PATIENT'S POST-OPERATIVE VISUAL ACUITY IS 20/20. AFTER REVIEWING A VIDEOTAPE OF THE SURGERY, THE SURGEON NOTICED THERE WAS A POSSIBLE DEFECT ON THE SURFACE OF THE PATIENT INTERFACE APPLANATION LENS. THE POSSIBLE LENS DEFECT WAS IN THE SAME LOCATION AS THE AREA OF INEFFECTIVE PHOTODISRUPTION. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL TEAR AND POSSIBLE SURGICAL INTERVENTION.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=427566

DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP. DURING THE PROCEDURE, A SCREW HAD LOOSENED FROM THE DELIVERY SYSTEM AREA AND THE WASHER LANDED ON THE PATIENT'S FOREHEAD. THE PATIENT WAS NOT INJURED AND THE SURGERY CONTINUED WITHOUT INCIDENT. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL ABRASION AND POSSIBLE SURGICAL INTERVENTION.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=483344

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 09/12/2003 MDR TEXT KEY: 1674969 Patient Sequence Number: 1
SUBSEQUENT TO LASIK SURGERY WITH THE INTRALASE FS LASER, THE PT'S VISUAL RECOVERY HAS BEEN DELAYED. THE SURGERY WAS UNEVENTFUL, HOWEVER, POSTOPERATIVELY, THE SURGEON OBSERVED WHAT HE DESCRIBED AS AN "ORANGE PEEL EFFECT" WITH DELAYED VISUAL RECOVERY. PREOPERATIVELY, THE PT'S BEST CORRECTED VISULA ACULTY (BCVA) WAS 20/20 IN BOTH EYES. AT THE 19-DAY POSTOPERATIVE VISIT, THE PT'S BCVA WAS 20/30 OD AND 20/60 OS. AT THE 2-MONTH POSTOPERATIVE VISIT, THE PT'S BCVA IMPROVED TO 20/25 OD. HOWEVER THE OS EYE WAS 20/50. THERE HAVE BEEN NO SECONDARY SURGICAL INTERVENTIONS PERFORMED AT THIS TIME.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=475323

THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAPS FOR BILATERAL LASIK SURGERY IN 2003. A 120 MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER, HOWEVER WHEN THE SURGEON ATTEMPTED TO LIFT THE FLAP (IN THE OS EYE) WITH A SLADE SPATULA, HE CREATED A FALSE CHANNEL WITH THE SPATULA. THE SURGEON THEN INTRODUCED THE SPALULA FROM THE OPPOSITE SIDE AND THE FLAP LIFTED SUCCESSFULLY AND THE EXCIMER TREATMENT WAS PERFORMED. AT THE ONE DAY POSTOP VISIT, THE PATIENT PRESENTED WITH FLAP EDEMA, HAZO, RIDGES, AND BLURRY VISION. THE PATIENT WAS RETERRED TO A CORNEAL SPECIALIST FOR POSTOPERATIVE FOLLOW-UP. AT THE ONE-MONTH POSTOPERATIVE VISIT. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (DCVA) IN THE AFFECTED (OS) EYE WAS 20/200, COMPARED WITH THE PATIENT'S PREOPERATIVE BCVA OF 20/20).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=474912

SUBSEQUENT TO LASIK SURGERY WITH USE OF THE INTRALASE FS LASER TO CREATE THE CORNEAL FLAP, A PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATATIS (DLK) BILATERALLY. AT APPROXIMATELY ONE WEEK POSTOPERATIVELY, THE DLK HAD PROGRESSED TO STAFE IV AND CENTRAL FOLDS WERE OBSERVED. THE PATIENT WAS TREATED WITH TOPICAL STERIODS; HOWEVER THE FLAPS WERE NOT LITTED OR RINSED. AT THE 3 WEEK POSTOPERATIVE VISIT, THE PATIENT'S BEST CORRECTED VISUAL ACUITY HAD DECREASED MORE THAN 2 LINES AND RESULTED IN INDUCED ASTIGMATISM.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=474978

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646970 Patient Sequence Number: 1
THE INTRALASE FS LASER AND INTRALASE PATIENT INTERFACE WERE USED TO CREATE THE CORNEAL FLAPS FOR BILATERIAL LASIK SURGEON. DURING SURGERY ON TEH OS EYE, THE DISSECTION WAS INCOMPLETE AND RESULTED IN A TORN CORNEAL FLAP. THE INCOMPLETE DISSECTION WAS LATER ATTRIBUTED TO A BENT PATIENT INTERFACE CONE. THE LASIK SURGERY WAS THEN PERFORMED SUCCESSFULLY AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE AFFECTED EYE WAS 20/25 AT THE ONE WEEK POSTOPERATIVE VISIT. THE PATIENT'S PREOPERATIVE BCVA WAS 20/20. ALL THE TIME OF THE COMPLAINT CLOSURE, THE PATIENT'S BCVA IMPROVED TO 20/20 AT THE 3 MONTH POSTOPERATIVE VISIT. 6 MONTHS LATER INTRALASE WAS NOTIFIED THAT THIS PATIENT HAD LASIK ENHANCEMENT PERFORMED ON BOTH EYES, THE ENHANCEMENT PROCEDURE WAS NOT PERFORMED AS A RESULT OF THE COMPLICATION. DURING THE ENHANCEMENT ON THE OS EYE, A 160-MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER. THE SURGEON OBSERVED GAS BUBBLES FORMING UNDER THE PREVIOUS FLAP, SO HE WAITED 5 HOURS AND THEN CRCATED A SECOND FLAP AT A DEPTN TO 200 MICRONS. THE FLAP WAS LIFTED SUCCESSFULLY AND THE EXCIMER ABLATION WAS PERFORMED. AT THE PATIENT'S MOST RECENT POSTOPERATIVE VISIT, THE BCVA IN OS EYE HAD DECREASED FROM 20/20 PREOPERATIVELY TO 20/50 AND IRREGULAR ASTIGMATISM WAS OBSERVED. THE SURGEON IS CONSIDERING PERFORMING A CUSTOM EXCIMER TREATMENT.

ADDITIONAL MANUFACTURER NARRATIVE
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646973
THE INIRALASE PATIENT INTERFACE CONE WAS RETURNED TO INTRALASE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION REVEALED THAT THE CONE DID NOT MEET SPECIFICATIONS. ONE OF THE FOUR CONE LEGS WAS SLIGHTLY BENT.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=637281

"It was reported to intralase that subsequent to bilateral "bladeless" lasik, the pt developed severe "dlk," which was treated with long-term topical and oral steroids. Posterior subcapsular cataracts formed and intrastromal scarring resulted. Cataract surgery will be performed to prevent permanent impairment. It should be noted that the reporting physician assumed this pt's follow-up care and was not the surgeon who performed the lasix procedure. "

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=916768

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 on patient's left (os) eye. The doctor reported he experienced a difficult flap lift, excessive opaque bubble layer (obl) and centration difficulties as patient had loose epithelium. A bandage contact lens (bcl) was placed due to an irregular corneal surface. The patient's preoperative best corrected visual acuity (bcva) was 20/20-2 os. Patient's postoperative bcva is 20/60 os. Current bcva has been requested from the facility, but information has not been provided as of 9/21/07. If additional information becomes available, a supplemental report will be submitted. The association between the event and the device is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=908570

Manufacturer Narrative
An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas visited the site in 2007 and performed an investigation. In summary, the probable root cause appears to be associated with the site not draining their sterilizer regularly. The cas advised site regarding sterilization practices and the site has since changed their statim 2000 sterilizer to a graham autoclave sterilizer. In addition, surgical instruments are now put in an ultrasonic cleaner, packaged, and then autoclaved. Dlk has resolved since noted changes were implemented.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. Postoperatively (eight days later) the patient was presented with central diffuse lamellar keratitis (dlk) in both eyes (ou). The right (od) eye with stage 2+ dlk and the left (os) with 4+ dlk and slight corneal melting. A flap lift and rinse was performed on left eye only. The patient was treated with steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20. Patient's postoperative bcva is 20/30 +0. 25+0. 25x115 os with mild haze and 20/20 od. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=907878

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the next day) the patient presented with diffuse lamellar keratosis (dlk) and central striae. The following month, the patient was diagnosed with central toxic keratopathy (ctk), slight central corneal melting on the left (os) eye and doctor opted to perform a flap lift and rinse on both (ou) eyes. The patient was prescribed with topical steroids and has responded to treatment. The patient's preoperative best corrected visual acuity (bcva) want 20/20 ou. Patient's postoperative bcva is 20/20 od and 20/25+2 os. Dlk and ctk have resolved. The association between the event and the device is unknown.

Manufacturer Narrative
An intralase clinical applications specialist (cas) provided surgery support in 2007, and has been in contact with the physician obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas and physician believe that the cause of dlk is due to something in the surgical suite environment. The site has recently changed their air filter, started using a disposable canulas, and changed their cleaning solution for the instruments. After implementing these changes, the hospital has noticed a significant improvement in patient outcomes. An intralase field service engineer (fse) performed preventive maintenance on july 25, 2007 and the laser system met specifications and performed as intended.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=885873

Manufacturer Narrative
On 07/2007, an intralase field service manager visited the site, provided surgery support and performed preventative maintenance. The laser system was assessed, and met all specifications and performed as intended. There were no issues observed during surgery support.

Event Description
The intralase fs laser was used to create bilateral corneal flaps lasik surgery in 2007. During surgery, the flap on the left eye (os) became decentered. Postoperatively, the pt presented with mild microstriae os and the following month, intervention was performed to lift, irrigate, and smooth the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in both eyes. Postoperatively, the pt's bcva is 20/16 in the left eye and 20/25 in the right eye. The association between the event and the device is unk.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=873539

Manufacturer Narrative
In 2007, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Cas inquired into instrument and surgical preparation practices, as well as technique. The cas did not identify any unusual practices, and found the laser system met specifications and performed as intended. One day later, an intralase field service engineer (fse) visited the site, performed minor alignment of the oscillator and found the laser system met specifications and performed as intended. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create corneal bilateral flaps for lasik surgery in 2007. One week postoperatively, the pt presented with central toxic keratopathy (ctk), and stria at which time the doctor opted to perform stria removal and repositioned the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in the right (od) eye and 20/20 in the left (os) eye. The pt's current postoperative bcva is 20/30 od, 20/30 os and 20/25 in both (ou) eyes. The association between the event and the device is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=873551

Manufacturer Narrative
On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with trace diffuse lamellar keratitis (dlk) on the right (od) eye and stage 2+ on the left (os) eye. A flap lift and rinse was performed the following day on the left (os) eye only. Pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 both (ou) eyes. Postoperative bcva is 20/100 od and 20/15-2 os. The od eye was corrected for near vision and the bcva taken was distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=873552

Manufacturer Narrative
On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with 2+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed four days later, and pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) in the right (od) eye was 20/20-1 and 20/25 in the left (os) eye. Postoperative bcva is 20/20 od and 20/50 os. The os eye was corrected for near vision and the bcva taken was for distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=861058

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007, in both (ou) eyes. One day postoperatively (the followig day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20 ou. The pt's current postoperative bcva is 20/50 + od and bcva 20/30+os. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative
An field svc engineer (fse) performed preventive maintenance on 04/19/07, and the laser sys performed as intended, and met specifications. On 05/08/07, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any usual environmental or surgical technique issues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=861060

Event Description
The intralase fs laser was used to create a corneal flap for lasik surgery in 2007, in the left (os) eye. One day postoperatively (the next day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20. The pt's current postoperative bcva is 20/40. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative
On 4/19/07, a field svc engineer (fse) performed preventive maintenance, and the laser maintenance performed as intended, and met specifications. On 5/08/07, an intralase clinical application specialist (cas) visited the site, and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any unusual environmental or surgical technique issues.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=842914

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the next day, the pt presented with stage 1+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed prior to that day. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (bcva) is 20/25 od and 20/25+2 os. The pt is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative
On 2/06/07, a field service engineer performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. On 3/15/07, an intralase clinical applications specialist (cas) visited the site and noticed the laser settings are being modified on a continuous basis, against cas' advice. The site has had on-going construction adjacent to the surgical suite since 2006. An environmental company evaluated the surgical site 1/25/07 and noted the ventilation system was not working effectively, most likely due to an improperly installed air filter. Even though the site uses powder free gloves, white powder was observed on equipment and noted in the environmental report. On 3/29/07, an intralase director of clinical support found the laser system met specifications and performed as intended. It should be noted the organizations recommends treating stages 1 & 2 dlk with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. Air filters haven't been changed as recommended by environmental company on 01/25/2007.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=843993

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou) and was prescribed topical and oral steriods. Two days later, the doctor performed a flap lift and rinse. Four days later, postoperative check up, the left eye (os) had progressed to stage 4 dlk. The following month, postoperative check up, dlk was resolved but central scarring present. The patient's preoperative best corrected visual acuity (bcva) was 20/16 ou. Postoperative bcva as of the same day, in the right (od) was 20/16 and 20/125 os. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unknown.

Manufacturer Narrative
In 2007, an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance-no adjustments were required. Thirteen days later, an fse returned to site due to dlk report and calibarated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas)has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was no identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=844315

Event Description
The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 in the left (os) eye. One day postoperatively, the patient presented with stage 2 diffuse lamellar keratitis (dlk). The patient was prescribed topical and oral steroids. Two days later, the doctor performed a flap lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/12. 5 both (ou) eyes. Postoperative bcva as of the following month was 20/12. 5 ou. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative
On 3/06/07 an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance - no adjustments were required. The following month, an fse returned to site due to dlk report and calibrated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was not identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=840155

Event Description
The inralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the following day) the pt presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou four days later. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative bcva is 20/25 od and 20/20 os. The pt responded to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative
In 2007, a field service engineer inspected the laser. The laser sys met specs and performed as intended. Five days later, an intralase clinical applications specialist (cas) provided surgery support and observed mold inside the sterilizer. Cas recommended replacement with new sterilizer and site followed recommendation. Additionally, cas modified laser settings. It should be noted that the american academy of ophthalmology (aao) recommends treating stages 1 & 2 dkl with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. The physician did not follow the recommended treatment protocol.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=835599

Event Description
The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with grade 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou on the same day. Dlk seemed to progress to grade 3-4+ in the right (od) eye and grade 3+ dlk in the left (os) eye so a second lift and rinse was performed ou three days later, and a third lift and rinse was performed ou the following day. Central cornea of od began melting on the same day. Patient was treated with oral and topical steroids and a bandage contact lens was placed after the first lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (ucva) is 20/50 od and 20/20 os. The patient's next follow up visit is scheduled for approx one and a half month later. Additional information will be supplied to fda when received. The association between the event and the device is unknown.

Manufacturer Narrative
On 02/06/07, a field service engineer inspected the laser and performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. The following month, an intralase clinical applications specialist (cas) provided surgery support and observed the site has been modifying their laser settings on a continuous basis, against the advice of the cas. Additionally, the site has had on-going construction adjacent to the surgical suite since 2006 that is stirring up dust and debris in the area. An environmental company evaluated the surgical site and noted that the ventilation system was not working effectively, most likely due to an air filter that was improperly installed. White powder was observed on equipment and noted in the environmental report, even though the site uses powder free gloves.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=916768

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 on patient's left (os) eye. The doctor reported he experienced a difficult flap lift, excessive opaque bubble layer (obl) and centration difficulties as patient had loose epithelium. A bandage contact lens (bcl) was placed due to an irregular corneal surface. The patient's preoperative best corrected visual acuity (bcva) was 20/20-2 os. Patient's postoperative bcva is 20/60 os. Current bcva has been requested from the facility, but information has not been provided as of 9/21/07. If additional information becomes available, a supplemental report will be submitted. The association between the event and the device is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=966623

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One week post-op (approximately a week later), patient was noted to have elevated intraocular pressure (iop) in the right (od) eye due to pigmentary glaucoma. The patient's preoperative best corrected visual acuity (bcva) was 20/15 od. Postoperatively, the patient's bcva is 20/40 od. Patient treated with medications to address the increased iop. Updated patient status was requested, but information has not been provided to filutowski eye institute by co-managed office as of approx two months later. However, if additional information becomes available, supplemental report will be submitted to fda. The association between the event and the device is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037638

I had lasik surgery - ladarvision 4000, with intralase at eye institute. Since then, i have had starburts at night, severe and painful dry eye, and increased floaters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1037663

I need contacts for both eyes, but i had lasik on my right eye only due to my flexible spending account situation. I now have a harder time seeing out of that eye at night because of the starbursting that was supposed to go away after i stopped using the medicated eyedrops. The doctor told me it would be a day or two after i stopped using the eyedrops that my starbursting would go away. It has now been three weeks since surgery, and there is no improvement with the starbursting. My left eye still sees normally at night when i wear my contact. My right eye vision has been corrected, but i notice smaller starbursts during the day and big starbursts at night. I was planning to have the left eye done as well, but i don't want to do it until i know my right eye night vision improves. I might be part of the 5% who experience permanent starbursting after the surgery since the effect is taking longer to go away than the doctor expected. I have a true before and after comparison and i am not yet satisfied with the results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=697992

I had visx customvue lasik with intralase in 2005. I was convinced, by a dr that i had been seeing for more than ten years, to have the surgery during a routine examination. I had been struggling with contact lenses due to my high astigmatism for years so lasik seemed like the perfect solution. I had heard so many good things about the surgery and i never imagined that my dr would mislead me. My mainifest refraction was: od -0. 25 -4. 25 x 95, os -0. 75 - 3. 25 x70. My vavescan refraction was: od +0. 3. 2 -3. 80 x 98, os -0. 52 -3. 25 x 71. My pupils were measured at 8. 3 mm twice before surgery. I was told that i was a good candidate. I do not feel that the procedure should be approved for a pt with very large pupils and such a high prescription. The computer recorded this info before treatment, however, my physician appearently felt that i was an "excellent candiate. " aside from being a bad candidate i also developed micro striae in both of my flaps which may have been caused by inflammation from the intralase laser. These folds were kept hidden from me despite my constant complaints of ghost imaging and glare. I eventually got a second opinion and underwent flap suturing with another surgeon which made my striae -and symptoms- much worse. At this point my acuity is correctable to 20/20 with glasses but my vision in low light is terrible. I also have severe dry eye after seven months which causes constant burning and discomfort.