ACRYSOF® SA60AT (REF SA60AT.330)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SINGLE-PIECE ACRYLIC FOLDABLE IOL,UV-ABSORBING POSTERIOR CHAMBER LENS (IOL/PC),13.0mm LENGTH, 6.0mm BICONVEX OPTIC, PLANARHAPTICS. · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380650141293), received between Dec 23, 2022 and Feb 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Failure to Advance1
- Failure to Deliver1
- Material Deformation1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Failure to Deliver; Material Deformation
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, WITH A DESCRIPTION OF IT WAS IMPOSSIBLE TO INSERT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS IMPLANTATION COULD NOT BE PERFORMED DUE TO THE IMPLANT BECOMING BLOCKED INSIDE THE CARTRIDGE DURING INJECTION. A SECOND ATTEMPT WAS MADE USING A DIFFERENT INJECTOR AND CARTRIDGE. HOWEVER, THE IMPLANT¿S OPTIC WAS FOUND TO BE DAMAGED, PREVENTING IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441773 ↗MalfunctionJul 12, 2024Scratched Material; Scratched Material
A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTING THE LENS OBSERVED A SCRATCH ON THE LENS. THERE WAS NO PROBLEM DURING FOLDING OF LENS. THE SCRATCH WAS NOT IN THE MIDDLE OF THE LENS AND LENS WAS LEFT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT STATUS WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19729044 ↗MalfunctionApr 18, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS DEFECTIVE, LENS WAS STUCK IN THE CARTRIDGE. THE BACKUP LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19132328 ↗MalfunctionDec 23, 2022Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available
A MATERIALS MANAGER REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT LOAD AND KEPT MOVING AROUND. PATIENT CONTACT WAS OBSERVED AND PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16041759 ↗
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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