Clareon SY60WF (UDI 00380652251228)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 00380652251228), received between Aug 28, 2024 and Sep 27, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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

Positioning Failure2
Break1
Material Twisted/Bent1

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjurySep 27, 2024Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, WHILE IMPLANTING THE IOL INTO THE PATIENT EYE, THE IOL WAS EJECTED INVERTED. THEY TRIED TO FLIP IT BACK OVER, BUT COULD NOT, SO REMOVED THE IOL AND REPLACED WITH A COMPANY LENS IN AN INITIAL PROCEDURE. FURTHERMORE, A HAPTIC WAS TORN OFF WHILE THE IOL WAS BEING REMOVED. ADDITIONAL INCISION WAS CRATED WHEN TRIED TO FLIP THE IOL BACK OVER. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE IOL. SUBCONJUNCTIVAL INJECTION WAS APPLIED IN THE END. AFTER REVIEW OF SURGICAL VIDEO PROVIDED BY THE CUSTOMER, IT WAS NOTICED THAT THE SURGERY INVOLVED THREE LENSES. WITH THE FIRST IOL, THE HAPTIC BROKE DURING DELIVERY DUE TO A PLUNGER UNDERRIDE/EXTENDED HAPTIC. THE SECOND LENS WAS DELIVERED UPSIDE DOWN DUE TO A STRAIGHT LEADING HAPTIC AND NON ROTATION OF THE CARTRIDGE. THE THIRD LENS, A MULTI PIECE LENS REMAINS IMPLANTED. THE FIRST IOL UNFOLDED POSTERIOR SURFACE UP DUE TO THE TRAPPED TRAILING PORTION OF THE OPTIC AND HAPTIC, WHICH WERE STILL IN THE CARTRIDGE. WHEN THE PLUNGER/CARTRIDGE WERE RETRACTED, THIS BROKE THE TRAILING HAPTIC. THE LENS WAS PULLED INTACT OUT OF THE INCISION WITH FORCEPS. INCISION WAS NOT
Patient problems: Insufficient Information
MAUDE report 20320278 ↗
MalfunctionAug 28, 2024Break; Positioning Failure; Break; Positioning Failure
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, WHILE IMPLANTING THE IOL INTO THE PATIENT'S EYE, THE IOL WAS EJECTED INVERTED. THEY TRIED TO FLIP IT BACK OVER, BUT COULDN'T, SO REMOVED THE IOL AND REPLACED WITH A COMPANY LENS IN AN INITIAL PROCEDURE. FURTHERMORE, A HAPTIC WAS TORN OFF WHILE THE IOL WAS BEING REMOVED. ADDITIONAL INCISION WAS CRATED WHEN TRIED TO FLIP THE IOL BACK OVER. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE IOL. SUBCONJUNCTIVAL INJECTION WAS APPLIED IN THE END.
Patient problems: Insufficient Information
MAUDE report 20083959 ↗

Device details

UDI-DI	`00380652251228`
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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