Clareon SY60WF (UDI 00380652251327)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652251327), received between Jun 10, 2024 and Apr 20, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Deliver1
Patient problems
- Halo1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Failure to Deliver
A PHARMACIST REPORTED THAT THE IMPLANT HAD BEEN FOLDED INSIDE THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS WAS DISCARDED.
Patient problems: Insufficient Information
MAUDE report 24925061 ↗InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SHADOW IN TOP LEFT CORNER OF LIGHT AND BLUE/FIOLET SHADOWS. THE PATIENT ALSO HAS HALOS AROUND STREET LIGHTS AND CAR LIGHTS .THE SHADOW APPEARS WHEN IT WAS DARK AROUND THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: Halo; Visual Disturbances
MAUDE report 19497003 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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