ACRYSOF® SA60WF (REF SA60WF.250)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
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652332767), received between Sep 20, 2021 and May 7, 2024 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device3
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Failure to Eject1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Eye Injury1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF NON STERILE/MATERIAL DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19259513 ↗InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASED QUALITY OF VISION, BLURRY VISION EVEN WITH GLASSES. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY ONE YEAR AFTER INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 18913879 ↗MalfunctionNov 15, 2023Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS WAS SCRATCHED. A REPLACEMENT LENS WAS USED DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18137871 ↗MalfunctionJan 16, 2023Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A STRING OR ABRASION ON THE OPTICS OF THE LENS AND WHICH COULD NOT REMOVE. THE LENS NOT REMOVED DUE TO INCREASED RISK OF COMPLICATION. THERE WAS NO NEGATIVE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16173853 ↗MalfunctionNov 28, 2022Defective Device; Defective Device
A REPORT WAS RECEIVED FROM THE DISTRIBUTOR AND REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15867990 ↗MalfunctionNov 24, 2022Defective Device; Defective Device
IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE LENS WAS FAULTY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15861054 ↗MalfunctionJul 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, LENS FOUND TO HAVE A CREASE GOING DOWN THE OPTIC AFTER INSERTION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, CREASE WAS SEEN ON POST OPERATION EXAM PER SURGEON.
Patient problems: Insufficient Information
MAUDE report 15130673 ↗MalfunctionJul 19, 2022Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE OPTIC AND THE HAPTIC WERE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT SCHEDULED PROCEDURE BE COMPLETED ON THE SAME DAY BY USING BACK UP LENS. THERE WAS PATIENT CONTACT, BUT THERE IS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15050852 ↗MalfunctionMay 3, 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 STRING WAS FOUND ON THE LENS. STRING WAS REMOVED BY IRRIGATION AN ASPIRATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14265103 ↗InjurySep 20, 2021Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS CAUGHT IN THE CARTRIDGE AND THE HAPTIC WAS SQUEEZED OFF. THE INCISION WAS ENLARGED AND THE PROCEDURE WAS COMPLETED WITH A BACK-UP LENS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Eye Injury
MAUDE report 12501971 ↗
Other intraocular lens devices
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- 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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