ACRYSOF® SA60WF (REF SA60WF.180)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652332620), received between Dec 2, 2021 and Feb 6, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
Most reported problems
Device problems
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE BROKEN HAPTIC. THE PROCEDURE WAS COMPLETED BY USING THE BACKUP LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE ISSUE HAD BEEN OBSERVED DURING LOADING.
Patient problems: Insufficient Information
MAUDE report 24278952 ↗MalfunctionMar 20, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF WHEN LOADING THE LENS, IOL WAS HARD, DID NOT PUSH UP TO THE TIP OF THE CARTRIDGE. ALSO STATED THEY HAVE USED COMPANY ANOTHER LENS IN WHICH THEY HAVE LOADED THE LENS INTO THE INJECTOR SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21653712 ↗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 RIGHT EYE.
Patient problems: Insufficient Information
MAUDE report 18683883 ↗MalfunctionNov 28, 2022Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE IOL. THE LENS REMOVED FROM THE EYE DURING INITIAL PROCEDURE. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15867992 ↗MalfunctionDec 23, 2021Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13074200 ↗MalfunctionDec 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON SAW A GASH IN THE OPTIC AFTER IT UNFOLDED AND THE LENS WAS TAKEN OUT IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12917302 ↗
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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