WaveLight 8065990941Recalls & reported problems
Alcon Laboratories, Inc. · WAVELIGHT FS200 · Class 2
Quick summary
This Alcon WaveLight femtosecond laser is used in eye surgery. Its 475 adverse event reports often describe incomplete or misaligned cuts, thin or torn corneal flaps, and sudden loss of suction. There are no deaths and 190 injuries. Reports rose from 24 in the prior 12 months to 43 in the last 12. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 460
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 460 adverse event reports that list this exact device (DI 00380659909412), received between Mar 1, 2021 and Sep 16, 2026 — classified as 179 injuries, 281 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (269 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Align269
- Adverse Event Without Identified Device or Use Problem119
- Unexpected Therapeutic Results29
- Decrease in Suction21
- Suction Problem21
- Insufficient Device Problem Information11
- Appropriate Device Problem Term/Code Not Available10
- Intermittent Continuity5
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available150
- Insufficient Information122
- Keratitis92
- No Clinical Signs, Symptoms or Conditions67
- Visual Disturbances15
- Corneal Perforation9
- Corneal Scar5
- No Information4
Recent adverse event reports
The 25 most recent of 460 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Unexpected Therapeutic Results
A Physician reported that during creation of a flap surgeon observed an uncut flap in the left eye of a patient during refractive surgery. No patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789196 ↗MalfunctionMay 27, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE THIN FLAP IN THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT TWO, UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 25302028 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT A PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN A LEFT EYE OF THE PATIENT AFTER REFRACTIVE SURGERY WITH A VISUAL ACUITY OF ONE DIOPTER POST ONE MONTH. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES FOR PATIENT¿S INITIALS (B)(6), LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24818737 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE RIGHT EYE AFTER REFRACTIVE SURGERY. THE PATIENT¿S SYMPTOMS SUBSEQUENTLY IMPROVED. THE PROCEDURES WERE PERFORMED BY TWO EXPERIENCED SURGEONS. THE HOSPITAL CONFIRMED THAT THERE HAVE BEEN NO RECENT CHANGES IN POSTOPERATIVE MEDICATION PRACTICES, AND NO CHANGES TO SURGICAL INSTRUMENTS. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT INITIAL (B)(6) IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24724050 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE RIGHT EYE AFTER REFRACTIVE SURGERY. THE PATIENT¿S SYMPTOMS SUBSEQUENTLY IMPROVED. THE PROCEDURES WERE PERFORMED BY TWO EXPERIENCED SURGEONS. THE HOSPITAL CONFIRMED THAT THERE HAVE BEEN NO RECENT CHANGES IN POSTOPERATIVE MEDICATION PRACTICES, AND NO CHANGES TO SURGICAL INSTRUMENTS. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT INITIAL NZ IN THE RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24723092 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN A LEFT EYE AFTER REFRACTIVE SURGERY. THE PATIENT¿S SYMPTOMS SUBSEQUENTLY IMPROVED. THE PROCEDURES WERE PERFORMED BY TWO EXPERIENCED SURGEONS. THE HOSPITAL CONFIRMED THAT THERE HAVE BEEN NO RECENT CHANGES IN POSTOPERATIVE MEDICATION PRACTICES, AND NO CHANGES TO SURGICAL INSTRUMENTS. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT INITIAL (B)(6) IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24715289 ↗MalfunctionMar 4, 2026Unexpected Therapeutic Results
A HEALTHCARE PROFESSIONAL REPORTED THAT SURGEON WAS UNABLE TO LIFT THE FLAP RESULTED IN THIN FLAP IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE TREATMENT WAS PAUSED BUT AFTER FEW DAYS SECONDARY SURGERY WAS PERFORMED AND THE PATIENT HAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510876 ↗MalfunctionMar 3, 2026Unexpected Therapeutic Results
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CREATION OF THE FLAP, THE CORNEAL FLAP WAS THIN NEAR THE SIDE CUT AT THE TEN O¿CLOCK POSITION, ADHESION AT FLAP EDGE WAS DIFFICULT TO SEPARATE THE FLAP IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THE SYMPTOMS WERE RESOLVED AND THE PATIENT WERE NOW RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496157 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENTS EXPERIENCED DIFFUSE LAMELLAR KERATITIS AND SOME CASES AFFECTED THE VISION IN THE UNKNOWN EYE OF A PATIENT, AFTER REFRACTIVE SURGERY. THE EXACT CASE WAS UNKNOWN. ADDITIONAL DETAILS REQUESTED. THE SURGEON PERFORMED ADDITIONAL SURGERY A FEW DAYS LATER AND THE PATIENT FULLY RECOVERED.
Patient problems: Keratitis
MAUDE report 24496006 ↗MalfunctionMar 3, 2026Unexpected Therapeutic Results
A HEALTHCARE PROFESSIONAL REPORTED THAT THE ACTUAL FLAP WAS FIFTEEN MICRONS THINNER THAN THE PLANNED FLAP THICKNESS IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES FOR UNKNOWN PATIENT, UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Insufficient Information
MAUDE report 24493767 ↗MalfunctionMar 2, 2026Unexpected Therapeutic Results
A HEALTH CARE PROFESSIONAL REPORTED ACTUAL FLAP WAS THINNER THAN THE PLANNED FLAP THICKNESS IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24487316 ↗MalfunctionFeb 26, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON TRIED TO LIFT THE FLAP, BUT IT WAS STICKY AND UNABLE TO LIFT THE FLAP WHICH RESULTED IN AN INCOMPLETE FLAP IN THE RIGHT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE PROCEDURE WAS ABORTED IN THE RIGHT EYE OF THE PATIENT. ADDITIONALLY NO SUCTION LOSS AND MEDICAL INTERVENTION REPORTED.
Patient problems: Insufficient Information
MAUDE report 24452414 ↗MalfunctionFeb 19, 2026Unexpected Therapeutic Results
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING FLAP CREATION IN THE LEFT EYE THE SURGEON HAD DIFFICULTY LIFTING THE FLAP. THE FLAP WAS EVENTUALLY ELEVATED BUT DID NOT GO AHEAD WITH THE TREATMENT / ABLATION AND NOTICED AN IRREGULAR STROMAL BED DURING REFRACTIVE SURGERY. AND THE RIGHT EYE WAS UNCOMPLICATED.
Patient problems: Insufficient Information
MAUDE report 24386488 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE RIGHT EYE AFTER REFRACTIVE SURGERY. THE HOSPITAL CONFIRMED THAT THERE WERE NO CHANGES IN POSTOPERATIVE MEDICATION REGIMENS, AND NO CHANGES WERE MADE TO SURGICAL INSTRUMENTS DURING THIS TIMEFRAME. THE HOSPITAL WAS UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AND RAISED CONCERNS REGARDING POTENTIAL INSTABILITY OF THE SYSTEM LASER ENERGY OR POSSIBLE QUALITY ISSUES RELATED TO THE PATIENT INTERFACE. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT INITIAL'S (B)(6), IN THE RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24361720 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN A LEFT EYE AFTER REFRACTIVE SURGERY. THE HOSPITAL CONFIRMED THAT THERE WERE NO CHANGES IN POSTOPERATIVE MEDICATION REGIMENS, AND NO CHANGES WERE MADE TO SURGICAL INSTRUMENTS DURING THIS TIMEFRAME. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT INITIALS (B)(6), IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24361716 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT THE PATIENT EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE AFTER REFRACTIVE SURGERY. THE PATIENT¿S CONDITION SUBSEQUENTLY RESOLVED. THE HOSPITAL CONFIRMED THAT THERE WERE NO CHANGES IN POSTOPERATIVE MEDICATION REGIMENS, AND NO CHANGES WERE MADE TO SURGICAL INSTRUMENTS DURING THIS TIMEFRAME. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT INITIAL'S (B)(6), IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Keratitis
MAUDE report 24361663 ↗InjuryFeb 17, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED FLAP WAS NOT CREATED IN THE UNKNOWN EYE OF THE PATIENT AS A RESULT SURGEON LIFTED THE FLAP WITH FORCEPS, ADDITIONALLY SURGERY WAS COMPLETED WITH SAME INTERFACE, AND THE ISSUE WAS RESOLVED DURING REFRACTIVE SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24361095 ↗InjuryFeb 13, 2026Unexpected Therapeutic Results
THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM (B)(6). A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE CORNEAL FLAPS WERE CREATED IN BOTH EYES. THE PLANNED FLAP THICKNESS WAS ONE HUNDRED TEN MICRONS HOWEVER, MIDWAY THROUGH THE SYSTEM SCAN, IT WAS FOUND TO BE AN EPITHELIAL FLAP. THE FLAP WAS REPOSITIONED WITH A DIFFERENT PATIENT INTERFACE, BUT THE SAME ISSUE OCCURRED MIDWAY THROUGH THE SYSTEM SCAN AND THE PROCEDURE WAS TERMINATED. THE SURGERY WAS RESCHEDULED. THE BANDAGE CONTACT LENS WAS PLACED. ON FURTHER EXAMINATION, IT WAS NOTED THAT CONJUNCTIVAL CONGESTION AND MILD CORNEAL EPITHELIAL EDEMA, NO OTHER OBVIOUS ABNORMALITIES OBSERVED IN RIGHT EYE OF THE PATIENT. THE FELLOW EYE WAS CLEAR AND NO OTHER OBVIOUS ABNORMALITIES OBSERVED. NEW INFORMATION WAS RECEIVED VIA FOLLOW-UP FROM COMPANY REPRESENTATIVE THAT THE SAME COMPLAINT DETAILS WERE CAPTURED IN THE FILE ID (B)(4). HENCE THIS FILE ID (B)(4) TO BE CANCELLED AND ALL THE INFORMATION AND DOCUMENTS WILL BE MOVED TO THE FILE ID (B)(4).
Patient problems: Conjunctivitis; Corneal Edema
MAUDE report 24334015 ↗MalfunctionFeb 5, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SMALL SEGMENT OF SIDE CUT WAS INCOMPLETE IN RIGHT EYE BECAUSE OF LIMITED APPLANATION DUE TO THE PATIENT'S ANATOMY WITH VERY SMALL CORNEAL DIAMETER. THE SURGEON WAS ABLE TO GET THE MAJORITY OF THE FLAP UP WITHOUT THE USE OF ADDITIONAL INSTRUMENTS AND PROCEEDED WITH TREATMENT. THE PROCEDURE WAS COMPLETED AND NO MEDICAL INTERVENTION REQUIRED.
Patient problems: Insufficient Information
MAUDE report 24269292 ↗MalfunctionFeb 2, 2026Unexpected Therapeutic Results
A PHYSICIAN REPORTED THAT DURING THE PROCEDURE A VERY STICKY FLAP WAS CREATED THAT WAS VERY DIFFICULT TO LIFT THE FLAP WITH CENTRAL ADHESIONS ON THE PATIENT'S RIGHT EYE DURING REFRACTIVE SURGERY. THE PATIENTS LEFT EYE FLAP WAS EASY TO LIFT WITH NO ISSUES. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24242866 ↗MalfunctionJan 30, 2026Unexpected Therapeutic Results
A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT HAD INCOMPLETE CUT SO FLAP COULD NOT BE LIFTED IN THE UNKNOWN EYE DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221641 ↗MalfunctionJan 30, 2026Unexpected Therapeutic Results
A PHYSICIAN REPORTED THAT DUE TO THE PATIENT'S THIN CORNEA, THE FLAP THICKNESS WAS NOT ADJUSTED, AND THE TREATMENT PROCEEDED. HOWEVER, DURING THE PROCEDURE, THE TUNNEL LASER AGAIN STRUCK THE PATIENT INTERFACE, AND THE BED CUT DEMONSTRATED CHARACTERISTICS OF A THIN FLAP. DESPITE REPLACING THE PATIENT INTERFACE A Z AXIS ERROR PERSISTED, LEADING THE PHYSICIAN TO HALT THE TREATMENT. THE NEXT TREATMENT PLAN WAS TO BE RECONSIDERED FOLLOWING THE PATIENT¿S CORNEAL RECOVERY IN THE RIGHT EYE DURING REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 24219526 ↗MalfunctionJan 28, 2026Unexpected Therapeutic Results
A PHYSICIAN REPORTED THAT DURING THE CREATION OF THE FLAP IN THE SECOND (LEFT) EYE, THE FLAP THICKNESS WAS SET TO ONE HUNDRED TEN MICRONS, AND NEGATIVE PRESSURE WAS ADEQUATE, WITH SUCTION FUNCTIONING NORMALLY. DURING LASER EMISSION, THE PHYSICIAN OBSERVED ABNORMAL LASER DELIVERY, NOTING THAT THE TUNNEL LASER WAS STRIKING THE FLATTENING CONE. THE PHYSICIAN SUSPECTED A Z AXIS ERROR IN THE LASER, WHICH RESULTED IN THE CREATION OF A THIN FLAP DURING REFRACTIVE SURGERY. THE LASER TREATMENT WAS PROMPTLY STOPPED, AND SUBSEQUENT ADJUSTMENTS WERE MADE, INCLUDING INCREASING THE FLAP THICKNESS SETTING TO ONE HUNDRED TWENTY MICRONS FOR THE TREATMENT. THE SURGERY WAS PROCEEDED NORMALLY, AND NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197479 ↗MalfunctionJan 21, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE FLAP CREATION THE PATIENT MOVED OR SQUEEZED THE EYE DUE TO THIS THE FLAP WOULDN'T COME UP RESULTED IN INCOMPLETE FLAP. THE FLAP WAS RECUT AND CREATED A NEW FLAP IN THE LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE FLAP CAME WITH NO ISSUES. THE PROCEDURE WAS COMPLETED AND NO MEDICAL INTERVENTION REQUIRED.
Patient problems: Insufficient Information
MAUDE report 24128781 ↗InjuryJan 14, 2026Unexpected Therapeutic Results
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE FLAP EDGE COULD NOT BE SEPARATED, RESULTING IN CORNEAL EPITHELIAL DAMAGE IN THE RIGHT EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.
Patient problems: Corneal Abrasion
MAUDE report 24064516 ↗
Other Ophthalmic femtosecond laser devices
- LenSx 8065998162Alcon Laboratories, Inc. · Ophthalmic femtosecond laser599 reports
- CATALYS SYSTEM CATALYS-UOptimedica Corporation · Ophthalmic femtosecond laser576 reports
- ALLY 70-00050-001LENSAR, Inc. · Ophthalmic Femtosecond Laser81 reports
- LIQUID OPTICS INTERFACE 0180-1201Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser51 reports
- ELITA EL2022Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser31 reports
- LIQUID OPTICS INTERFACE 0180-1401Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser28 reports
- CATALYS SYSTEM CAT PREC LSR SYSJohnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser14 reports
- INTRALASE TECHNOLOGY PI 0155-1825Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.