ACRYSOF® SN60WF (REF SN60WF.265)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC Natural IOL, SINGLE-PIECE ACRYLIC FOLDABLE PCL, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant

All models of ACRYSOF (353)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380655095737), received between Jul 5, 2022 and Mar 12, 2026 — classified as 5 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Break2
Scratched Material2
Defective Device1
Device Damaged by Another Device1
Failure to Unfold or Unwrap1

Patient problems

Insufficient Information4
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 12, 2026Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF LENS IT WAS NOTED THAT BOTH THE LENS HAPTICS WERE TIGHTLY ADHERED TO THE OPTIC AND COULD ONLY BE SEPARATED WITH DIFFICULT MANUAL MANIPULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT CURRENT CONDITION WAS GOOD. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 5 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579463 ↗
MalfunctionFeb 19, 2025Break; Scratched Material; Break; Scratched Material
A PHARMACIST REPORTED WITH A DESCRIPTION OF RECEIVED LENS BACK WITH A SCRATCH AND A BROKEN LEG. ANOTHER LENS WAS THEN PLACED AT THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21409346 ↗
MalfunctionJan 3, 2025Break; Scratched Material; Break; Scratched Material
A PHARMACIST REPORTED WITH A DESCRIPTION OF RECEIVED LENS BACK WITH A SCRATCH AND A BROKEN LEG. ANOTHER LENS WAS THEN PLACED AT THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21065424 ↗
MalfunctionJul 5, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE THERE WAS PROBLEM WITH INSERTION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED LENS WAS INJECTED BUT THE INJECTOR PLUNGER SLID OVER THE TOP OF THE LENS WHILE IN THE CARTRIDGE. IT WAS HALF WAY INSERTED WHEN IT WAS REMOVED DUE TO CONCERN THAT THE PLUNGER SCRATCHED THE LENS.
Patient problems: Insufficient Information
MAUDE report 14916788 ↗
MalfunctionJul 5, 2022Device Damaged by Another Device; Device Damaged by Another Device
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS INJECTED BUT THE INJECTOR PLUNGER SLID OVER THE TOP OF THE LENS WHILE IN THE CARTRIDGE. IT WAS HALF WAY INSERTED WHEN IT WAS REMOVED DUE TO CONCERN THAT THE PLUNGER SCRATCHED THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14916072 ↗

Device details

UDI-DI	`00380655095737`
Brand	ACRYSOF®
Model	SN60WF
Catalog no.	SN60WF.265
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 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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