ACRYSOF® SA60AT (REF SA60AT.250)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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652555906), received between Mar 12, 2023 and Sep 23, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Defective Device2
- Product Quality Problem2
- Device Damaged by Another Device1
- Failure to Eject1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Product Quality Problem
A health care professional reported with the description of intraocular lens (IOL) was defective (not specified).Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50867620 ↗MalfunctionApr 9, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED, IT WAS NOTICED THAT THE LENS WAS SCRATCHED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED USING UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24831456 ↗MalfunctionFeb 3, 2026Product Quality Problem; Defective Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT USED DUE TO A DEFORMITY ON ITS SURFACE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247002 ↗MalfunctionSep 9, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGERY WAS COMPLETED USING ANOTHER LENS AND THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 23001826 ↗MalfunctionSep 8, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE CARTRIDGE DAMAGED THE IOL (INTRAOCULAR LENS) WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY BY ANOTHER UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993753 ↗MalfunctionMar 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK IN THE LENS BODY WAS OBSERVED WHEN THE LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21662529 ↗MalfunctionJul 22, 2024Break; Failure to Eject; Break; Failure to Eject
A HEALTH PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK AT THE MOMENT OF INJECTING IT, WHEN REMOVING LENS FROM THE INCISION A HAPTIC GOT BROKEN. ANOTHER LENS OF THE SAME REFERENCE AND POWER IS ORDERED. ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 19790897 ↗MalfunctionMar 12, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). THE IOL WAS NOT IMPLANTED. ADDIIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16527284 ↗
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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