ACRYSOF® SA60WF (REF SA60WF.170)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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652332606), received between Apr 13, 2021 and Apr 18, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 Problem2
- Crack1
- Scratched Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Scratched Material; Scratched Material
A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT WHEN INSPECTED A LENS FOUND A SMALL SCRATCH ON THE OPTICS OUTSIDE THE VISUAL AXIS. THE LENS WAS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19132954 ↗InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE CAPSULE WAS OPENED WHEN LENS WAS PLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 13264541 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED SEEING A BAR AND YELLOW DOTS FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL). SHE REQUESTED AN IOL FOR ALLERGY TESTING AND NOTED THAT THE CORNEA DID NOT ACCEPT THE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE CONSUMER REPORTED BLURRED VISION. THE OPHTHALMOLOGIST RECORDED PERSISTENT DYSPHOTOPSIA, CORNEA GUTTATA, SEVERE PHOTOPHOBIA WITH VISUAL ACUITY OF 61.3%. NO COMPLICATIONS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED. ALLERGY TESTING INFORMATION PROVIDED. TYPE OF ALLERGY TESTING: EPICUTANEOUS TEST, RESULT NEGATIVE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment
MAUDE report 12437363 ↗MalfunctionApr 13, 2021Crack; Crack
A CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) CRACKED IN THE MIDDLE POSSIBLY DUE TO THE CARTRIDGE. THE LENS WAS REMOVED AND REPLACED WITHOUT INCIDENT. ADDITIONAL INFORMATION IS REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE IOL, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11660250 ↗
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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