ACRYSOF® SA60AT (REF SA60AT.060)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652555524), received between Dec 3, 2021 and May 20, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device2
- Material Opacification1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Defective Device; Defective Device
HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19350575 ↗MalfunctionApr 4, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19042538 ↗InjuryDec 3, 2021Material Opacification; Material Opacification
A PHYSICIAN HAS REPORTED THAT ONE YEAR FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR CAPSULE BECAME OPACIFIED AND A YAG CAPSULOTOMY WAS PERFORMED IN 2017, THE PATIENT HAD A VITRECTOMY AND EPIRETINAL MEMBRANE PEELING. THE RECENT TESTING CONFIRMED AN OPTIMAL RETINAL PROFILE. THIRTEEN YEARS AFTER THE INITIAL PROCEDURE A PHYSICIAN NOTED INITIAL OPACIFICATION OF THE IOL. NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO FILES ASSOCIATED FOR THIS REPORT. THIS COMPLAINT IS FOR THE RIGHT EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12925622 ↗
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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