LenSx 8065998162Recalls & reported problems
Alcon Laboratories, Inc. · LenSx Laser System · Class 2
Quick summary
This Alcon LenSx is a femtosecond laser system used in eye surgery. Of the 603 reports naming it, many describe the laser failing to align or to finish a cut during refractive surgery, with some describing capsule tears. The reports include 222 injuries and no deaths, and reports fell from 143 in the previous 12 months to 57 in the latest 12 months. 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
- 599
- Deaths reported
- 0
- Injuries reported
- 219
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 599 adverse event reports that list this exact device (DI 00380659981623), received between Mar 1, 2021 and Sep 29, 2026 — classified as 219 injuries, 380 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (264 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 Align264
- 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
- Insufficient Device Problem Information8
- Decrease in Suction7
Patient problems
- Insufficient Information239
- No Clinical Signs, Symptoms or Conditions145
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available119
- Capsular Bag Tear96
- Corneal Edema7
- Corneal Perforation7
- Blurred Vision3
- Corneal Abrasion2
Recent adverse event reports
The 25 most recent of 599 reports, 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 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT A PATIENT'S ANTERIOR CAPSULE MEMBRANE WAS TORN IN A NINETY-HUNDRED-DEGREE DIRECTION IN LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE INTRAOCULAR LENS WAS IMPLANTED, AND THE SURGERY WAS COMPLETED. THE PATIENT'S POSTOPERATIVE VISUAL EFFECTS HAD NOT BEEN AFFECTED
Patient problems: Capsular Bag Tear
MAUDE report 24813803 ↗MalfunctionApr 3, 2026Display or Visual Feedback Problem; Failure to Align
A PHYSICIAN REPORTED THAT CAPSULOTOMY WAS DECENTERED AND AS A RESULT SYSTEM GENERATED AN UNEXPECTED IMAGE IN THE RIGHT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE TREATMENT OUTCOME WAS UNFORTUNATE BUT THE PATIENT IS EXPECTED TO DO WELL POSTOPERATIVELY. THERE WAS NO CAPSULAR TEAR AND THE SURGEON DID NOT RE DOCK AS WELL. HE DOCKED ON THE EYE ONCE AND MAINTAINED SUCTION IN THE ENTIRE PROCEDURE. FURTHER THE SURGEON WHEN PUSHED THE ADVANCED PREPOSITIONING BUTTON, THE SYSTEM SHOULD HAVE PROMPTED THE DEVICE TO CAPTURE AN UPDATED DOCKED IMAGE BUT IT DID NOT.
Patient problems: Insufficient Information
MAUDE report 24783857 ↗MalfunctionMar 13, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE INADEQUATE INCISION PART WAS FOUND ON THE FLAP CREATION, WHEN THEY CHECKED A LINE-SHAPED SCRATCH WAS FOUND ON THE PATIENT INTERFACE SURFACE, FLAP INCISION WAS PERFORMED MANUALLY IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE CORNEA WAS UNEVEN, SURGEON WAS NOTICED SIMILAR DEFECTS SINCE LAST MONTH AND TOO MANY PROBLEMS.
Patient problems: Insufficient Information
MAUDE report 24598128 ↗MalfunctionMar 11, 2026Appropriate Device Problem Term/Code Not Available
A NURSE REPORTED THAT DURING THE CREATION OF FLAP, THE FLAP BECOMES SUPERFICIAL IN THE TEMPORAL REGION IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24566739 ↗MalfunctionMar 9, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM NOT CUTTING THE CAPSULOTOMY IN PROPER POSITION IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 24542584 ↗MalfunctionMar 6, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE ENERGY CALIBRATION WAS NOT REMAINING STABLE AND UNABLE TO PERFORM THE FLAP RESULTED THE CUT WAS INCOMPLETE IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THE PROCEDURE WAS NOT COMPLETED. THE SYSTEM DID NOT COMPLETE THE RHEXIS. THE SURGEON COMPLETED THE RHEXIS MANUALLY IN THE OPERATING ROOM.
Patient problems: Insufficient Information
MAUDE report 24530582 ↗MalfunctionFeb 27, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FLAP RESISTANCE IN THE UNKNOWN EYE DURING REFRACTIVE SURGERY.
Patient problems: Insufficient Information
MAUDE report 24469757 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD EXPERIENCED ANTERIOR CAPSULAR TEAR THAT TORE AROUND TO THE POSTERIOR CAPSULE IN RIGHT EYE OF THE PATIENT DURING REFRACTIVE SURGERY.
Patient problems: Capsular Bag Tear
MAUDE report 24455399 ↗MalfunctionFeb 26, 2026Failure to Cut; Firing Problem
A PHYSICIAN REPORTED THAT SYSTEM NOT EMITTING LASER AND FLAP BECAME FIRM AS A RESULT FLAP COULD NOT BE CUT PROPERLY IN THE LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY, ADDITIONALLY POSTOPERATIVE VISUAL OUTCOME NOT REACHING THE EXPECTED LEVEL. PATIENT REPORTED VISUAL DISTURBANCE WHICH PERSISTED. THE SYMPTOMS ARE CONTINUING.
Patient problems: Visual Impairment
MAUDE report 24452406 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE ANTERIOR TEAR IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY.
Patient problems: Capsular Bag Tear
MAUDE report 24402760 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.