ACRYSOF® SA60WF (REF SA60WF.175)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652332613), received between Apr 12, 2021 and Aug 22, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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
- Material Frayed1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Material Puncture/Hole; Material Puncture/Hole
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STAFF OBSERVED SMALL HOLES IN THE LENS. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT CONTACT AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872911 ↗MalfunctionJul 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WERE INSERTED AND REMOVED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22664856 ↗MalfunctionDec 14, 2021Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A ¿SCRATCH¿ CENTRALLY WAS NOTICED BY SURGEON. THE LENS WAS EXPLANTED AND A BACKUP LENS WAS IMPLANTED WITHOUT COMPLICATION. THE ¿SCRATCH¿ LOOKED LIKE A SQUIGGLY FUZZY, IT WAS NOT A STRAIGHT SCRATCH IN THE IOL. ADDITIONAL INFORMATION WAS RECEIVED FROM ACCOUNT MANAGER AND STATED. THERE WAS A ¿SQUIGGLY¿ MARK IN THE CENTRAL OPTIC THAT WAS CALLED A SCRATCH BUT THE APPEARANCE WAS NOT TYPICAL OF A LOADING ISSUE SCRATCH. THE COMPANY INJECTOR WAS FLAGGED AT THE ACCOUNT IN CASE THEY HAVE AN ISSUE WITH IT AGAIN THEY WILL KNOW THIS WAS ONE THAT WAS USED FOR THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12996316 ↗MalfunctionSep 2, 2021Material Frayed; Material Frayed
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE PIECE OF LENS MATERIAL HANGED FROM A PLACED LENS ON THE EDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12412153 ↗InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MATERIALS MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE "PROCEDURE CHANGED, VITRECTOMY PERFORMED, DIFFERENT MODEL USED." THERE WAS PATIENT CONTACT WITH THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11653608 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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