ACRYSOF® SA60WF (REF SA60WF.185)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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652332637), received between Apr 20, 2021 and Feb 12, 2024 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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
Most reported problems
Device problems
- Scratched Material3
- Appropriate Device Problem Term/Code Not Available2
- Crack1
- Device Contamination with Chemical or Other Material1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Visual Impairment1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED WITH THE DESCRIPTION OF GLISTERING FOLLOWING THE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH LEFT EYE.
Patient problems: Insufficient Information
MAUDE report 18684377 ↗InjuryMay 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
A PHYSICIAN REPORTED THAT DURING INITIAL IMPLANT PROCEDURE, PATIENT HAD ALMOST 2 DIOPTERS OF UNEXPECTED MYOPIA. LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17017157 ↗MalfunctionDec 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEPOSIT ON THE LENS WAS OBSERVED AND REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15931367 ↗MalfunctionFeb 11, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS NOTED TO HAVE A CENTRAL "SCUFF" DEFECT. LENS WAS CUT IN HALF AND REMOVED FROM PATIENT AND DISCARDED. NEW LENS OPENED AND IMPLANTED WITHOUT ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SAME REPORTER THAT, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512242 ↗MalfunctionFeb 2, 2022Scratched Material; Scratched Material
A FACILITY REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH ON LENS UPON INSERTION IN EYE. A NEW LENS WAS USED TO COMPLETE THE PROCEDURE. PATIENT WAS REPORTED TO BE DOING WELL, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO PROVIDED CONCOMITANT PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423969 ↗MalfunctionDec 30, 2021Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AND IT WAS CUT OUT BUT SECOND LENS PLACED WITH DIFFICULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13120242 ↗MalfunctionJun 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AN IOL REPLY CARD WAS RECEIVED WITH REPORT OF WASTED SMUDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12024200 ↗MalfunctionApr 20, 2021Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS CRACKED. THE CRACKED LENS WAS NOTICED FOLLOWING INSERTION OF THE LENS IN THE EYE. THE IOL WAS REPLACED WITH A BACK-UP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697140 ↗
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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