LenSxRecalls & 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
- 603
- Deaths reported
- 0
- Injuries reported
- 220
- Recalls
- 0
We found 2 models of LenSx by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 603 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Sep 29, 2026 — classified as 220 injuries, 383 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (265 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 LenSx problems
Device problems
- Failure to Align265
- Adverse Event Without Identified Device or Use Problem124
- Appropriate Device Problem Term/Code Not Available91
- Failure to Cut69
- Unintended Movement17
- Application Program Freezes or Fails to Launch13
- Decrease in Suction8
- Insufficient Device Problem Information8
Patient problems
- Insufficient Information241
- No Clinical Signs, Symptoms or Conditions147
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available119
- Capsular Bag Tear96
- Corneal Edema7
- Corneal Perforation7
- Blurred Vision3
- Corneal Abrasion2
LenSx models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LenSx 8065998162Ophthalmic femtosecond laser599 reports
- LenSx® 8065998163Unit, phacofragmentation4 reports
Recent LenSx adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Cut
A non-healthcare professional reported that the surgeon had an incomplete capsulerhexis and did not stain it with trypan blue leading to a tear in the capsule and the patient needing a sutured lens in unknown eye during refractive surgery.
Patient problems: Capsular Bag Tear
MAUDE report 50933281 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that, during LenSx-assisted cataract surgery in the patient's right eye, the capsular bag ruptured during cataract removal. No patient movement was reported, and the surgery was completed. An anterior vitrectomy was performed, and a one-piece intraocular lens was implanted.
Patient problems: Capsular Bag Tear
MAUDE report 50897320 ↗MalfunctionSep 24, 2026Appropriate Device Problem Term/Code Not Available
A non-healthcare professional reported that during a creation of a flap, surgeon observed a thin flap in the unknown eye of the patient, during refractive surgery.Patient interface suction was successfully achieved and maintained until the end of the procedure. The patient did not move during the case. Although the flap was noted to be thin, it was successfully lifted, and the procedure was completed on the same day.
Patient problems: Insufficient Information
MAUDE report 50883322 ↗MalfunctionSep 24, 2026Failure to Cut
A non-healthcare professional reported that the difficulty making the incisions, and the flap would not lift in unknown eye during refractive surgery.
Patient problems: Insufficient Information
MAUDE report 50879887 ↗MalfunctionSep 21, 2026Failure to Cut
A non healthcare professional reported that flap creation was poor during refractive surgery in the unknown eye of the patient.
Patient problems: Insufficient Information
MAUDE report 50841117 ↗MalfunctionSep 17, 2026Failure to Cut
A non healthcare professional reported that the flap resistance in the unknown eye of a patient, during refractive surgery.
Patient problems: Insufficient Information
MAUDE report 50798805 ↗MalfunctionAug 24, 2026Failure to Cut
A non-healthcare professional reported that the in this report of the during the capsulotomy procedure, at approximately the twelve-o clock position, the laser failed to complete the cut in unknown eye during refractive surgery.
Patient problems: Insufficient Information
MAUDE report 50402378 ↗MalfunctionAug 17, 2026Failure to Cut
A non-healthcare professional reported uncut capsulotomy about three to four clock hours inferior in the left eye during refractive surgery.There was no error message displayed, suction was maintained for the entire procedure. The Capsulorhexis was completed manually.There are multiple related reports for this facility. This report addresses the patient JJ, in the left eye and other manufacturer reports will be filed.
Patient problems: Insufficient Information
MAUDE report 50279604 ↗MalfunctionJul 10, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THERE IS A DIFFICULTY IN LIFTING THE FLAP AS IT WAS HIGHLY ADHERED IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 25782008 ↗MalfunctionJul 10, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED FLAP RESISTANCE IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25782007 ↗InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT SURGEON OBSERVED A CAPSULAR TEAR IN THE RIGHT EYE OF THE PATIENT DURING THE USE OF CAPSULAR TORIC MARKERS DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT INITIAL'S THREE, IN THE RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
Patient problems: Capsular Bag Tear
MAUDE report 25719535 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A SURGEON NOTICED A CAPSULOTOMY TEAR DURING THE REMOVAL OF CATARACT IN RIGHT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. A VITRECTOMY WAS PERFORMED WITH AN ALTERNATIVE THREE-PIECE MN6AC LENS IMPLANTATION.
Patient problems: Capsular Bag Tear
MAUDE report 24955079 ↗MalfunctionApr 21, 2026Failure to Cut
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CREATION OF FLAP A SURGEON OBSERVED STICKY FLAP IN THE RIGHT EYE OF A PATIENT DURING SURGERY ISSUE DURING REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 24941549 ↗MalfunctionApr 16, 2026Failure to Cut; Appropriate Device Problem Term/Code Not Available
A HEALTHCARE PROFESSIONAL REPORTED THAT SYSTEM DISPLAYED OPTICAL COHERENCE TOMOGRAPHY ERROR DURING DOCKING AND ADDITIONALLY FLAP WAS INCOMPLETE IN THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24895354 ↗MalfunctionApr 16, 2026Unintended Movement
A NON HEALTHCARE PROFESSIONAL REPORTED GANTRY WAS MOVING DOWN ON ITS OWN INTERMITTENTLY IN THE UNKNOWN EYE OF THE PATIENT DURING UNKNOWN TIMING.
Patient problems: Insufficient Information
MAUDE report 24893121 ↗
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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