Clareon SY60WF (UDI 00380652251365)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 18, 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 00380652251365), received between Feb 8, 2022 and Apr 30, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Defective Device2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Failure to Deliver1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Break
A PHYSICIAN REPORTED THAT BEFORE SURGERY, WHILE LOADING THE LENS THE HAPTICS WERE BROKEN WITH NO PATIENT CONTACT. SURGERY COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042345 ↗MalfunctionApr 24, 2026Failure to Deliver
A PHARMACY EMPLOYEE REPORTED THAT THE IMPLANT WAS STUCK INSIDE THE INJECTOR. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE REPORTER STATED THAT THE IOL WAS DISPOSED OF AND THE INJECTOR (UNSPECIFIED) USED WAS ALSO NOT AVAILABLE FOR RETURN. THE REPORTER FURTHER INDICATED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24977116 ↗MalfunctionAug 7, 2025Break; Break
A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED A BROKEN HAPTIC. BACK UP LENS WAS IMPLANTED. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739793 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON HAD CAME ACROSS 4 DIOPTER SURPRISE WITH LENS. THE OTHER EYE WAS NORMAL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20758080 ↗MalfunctionSep 5, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL WAS FOUND DEFECTIVE. THE IOL IS NOT AVAILABLE FOR RETURN, IT WAS SCRAPPED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20146750 ↗MalfunctionNov 8, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WITH TRAILING OPTIC EDGE AND TRAILING HAPTIC NEAR JUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15751478 ↗MalfunctionFeb 8, 2022Crack; Crack
ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGEON THAT, IT TOOK ABOUT 1 MINUTE ON AVERAGE FROM SETTING IOL TO THE CARTRIDGE TO INSERTING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13477582 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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