WaveLightRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 498
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls
- 0
We found 2 models of WaveLight by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 498 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Sep 16, 2026 — classified as 179 injuries, 319 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported WaveLight problems
Device problems
- Failure to Align269
- Adverse Event Without Identified Device or Use Problem119
- Decrease in Suction55
- Unexpected Therapeutic Results29
- Suction Problem21
- Insufficient Device Problem Information11
- Appropriate Device Problem Term/Code Not Available10
- Intermittent Continuity5
Patient problems
- Insufficient Information155
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available154
- Keratitis92
- No Clinical Signs, Symptoms or Conditions68
- Visual Disturbances15
- Corneal Perforation9
- Corneal Scar5
- No Information4
WaveLight models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WaveLight 8065990941Ophthalmic femtosecond laser460 reports
- WaveLight 8065998298Powered laser surgical instrument38 reports
Recent WaveLight adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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