Clareon SY60WF (UDI 00380652251341)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652251341), received between Sep 4, 2024 and Aug 28, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn3
- Break1
- Defective Device1
- Material Deformation1
- Optical Decentration1
- Product Quality Problem1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
- Corneal Edema1
- Inflammation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Break; Optical Decentration
A nurse reported that, Doctor implanted a lens and the patient has had a series of issues since her surgery which ended up removing a haptic. The haptic was amputated but it was unclear when. The lens was decentered on day 1 so there must have been some immediate defect not noted during surgery (surgery was uncomplicated). She later presented with delayed inflammation followed by corneal edema that was now known to be from a mobile/ floating haptic.Additional information has been requested but is not available at the time of this report.
Patient problems: Corneal Edema; Inflammation
MAUDE report 50498510 ↗MalfunctionJun 30, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT AN INTRAOCULAR LENS (IOL) USED DURING AN IMPLANT PROCEDURE WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25664067 ↗MalfunctionFeb 26, 2026Material Split, Cut or Torn
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THEY HAD BEEN ENCOUNTERING VERY UNUSUAL ISSUES WITH THE MONOFOCAL IMPLANTS, WHICH WERE BREAKING DURING FOLDING. THEY EXPERIENCED THIS PROBLEM FOUR TIMES IN ONE WEEK. THE IMPLANTS WERE STORED IN THE PHARMACY, WHERE THE TEMPERATURE WAS MONITORED (AROUND 20¿21°C), AND ON THE DAY OF THE PROCEDURES THEY WERE KEPT IN THE OPERATING ROOM, WHERE THE TEMPERATURE WAS TYPICALLY AROUND 18°C. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24455251 ↗MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS LOOP WAS CUT UPON INSERTION IN PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23727985 ↗MalfunctionMay 16, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS DAMAGED BEFORE IMPLANTATION. THERE WAS NO PATIENT HARM. THE SURGERY WAS DELAYED BY ONLY ONE MINUTE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035559 ↗MalfunctionMar 10, 2025Defective Device; Defective Device
NON HEALTH CARE PROFESSIONAL REPORTED DEFECT IN CENTER OF OPTIC THAT WAS NOT VISIBLE UNTIL IMPLANTED IN THE EYE. IT WAS REPORTED THAT THE LENS NEEDED TO BE CUT OUT AND EXPLANTED. ADDITIONAL INFORMATION STATED THAT THE EVENT WAS DUE TO THE MANUFACTURING ERROR AND PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 21561319 ↗MalfunctionSep 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A CUT IN THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH OTHER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134412 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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