Clareon SY60WF (UDI 00380652251631)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: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251631), received between Oct 14, 2022 and Mar 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Scratched Material2
Defective Device1
Failure to Advance1
Failure to Deliver1
Material Split, Cut or Torn1
Material Twisted/Bent1

Patient problems

Insufficient Information6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 24, 2026Failure to Deliver
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING INJECTOR UNDERNEATH LENS UPON IMPLANTATION, LENS SCRATCHED. THE LENS INSERTED AND REMOVED, AND REPLACEMENT LENS WAS USED AND PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. INJECTOR TO BE THROWN AWAY AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 24673503 ↗
MalfunctionMar 16, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 24603240 ↗
MalfunctionDec 29, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRACKED AND SCRATCHED. THE LENS WAS REMOVED FROM THE PATIENT EYE IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23906352 ↗
MalfunctionAug 20, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS AN IMPLANTATION FAILURE, THE LEADING HAPTIC DOES NOT FOLD. THE INCIDENT OCCURRED DURING THE ADVANCEMENT OF THE IMPLANT IN THE INJECTION SYSTEM. THE DEVICE CAME INTO CONTACT WITH THE PATIENT EYE. THE LENS WAS REPLACED WITH A SIMILAR ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22853140 ↗
MalfunctionNov 13, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATING DURING PRE-LOADED IOL PRIMING - LENS WAS IN PATIENT EYE AND GOT STUCK IN CARTRIDGE.(LENS WOULD NOT ADVANCE THROUGH CARTRIDGE). ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED EVENT OCCURRED DURING LOADING TIME.
Patient problems: Insufficient Information
MAUDE report 20675462 ↗
MalfunctionOct 14, 2022Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15605551 ↗

Device details

UDI-DI	`00380652251631`
Brand	Clareon
Model	SY60WF
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 28, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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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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