ACRYSOF® SA60AT (REF SA60AT.340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380650141309), received between Jan 12, 2022 and Apr 15, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRAP ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24886616 ↗
• MalfunctionJan 20, 2026Failure to Fold; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED IMPROPER FOLDING OF HAPTICS IN THE CARTRIDGE AND DAMAGE TO ONE OF THEM. UNSPECIFIED BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT IMPACT ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116558 ↗
• MalfunctionAug 12, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, DEFECTIVE INTRA OCULAR LENS (IOL). ADDITIONAL INFORMATION WAS RECEIVED; THE DEFECT WAS HAPTIC TILTED DURING IOL IMPLANTATION. IN THE SURGEON OPINION THE EVENT WAS CAUSED DUE TO TILTING OF THE HAPTIC IN THE CARTRIDGE. THE IOL WAS REMOVED ONE THE SAME PROCEDURE AND COMPLETED THE PROCEDURE WITH A NEW IOL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779994 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN IN CARTRIDGE AND NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077048 ↗
• MalfunctionJan 9, 2025Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE LENS WAS MISALIGNED IN THE CARTRIDGE AND WOULD NOT ENGAGE WITH THE PLUNGER. ANOTHER LENS WAS USED SUCCESSFULLY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111331 ↗
• MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE HAPTIC WAS SHORTER THAN THE OTHER, SO THE LENS WAS UNUSABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20513134 ↗
• MalfunctionJul 26, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, IT WAS NOTED THAT BOTH THE IOLS HAD SCRATCHES ON THEM. BOTH LENSES WERE REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396198 ↗
• MalfunctionJul 26, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED. THE LENSES WERE NOT REMOVED AND REPLACED IN AN INITIAL PROCEDURE, AS REPORTER CLAIMED THAT NEITHER LENS TOUCHED THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396194 ↗
• MalfunctionMar 24, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16611899 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT ENDED UP IN -5 DIOPTER MYOPIC POST SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE PRODUCT AND PATIENT DETAILS HAS BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 16608781 ↗
• InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THEY WERE UNABLE TO SUCCESSFULLY LOAD THE LENS INTO THE CARTRIDGE. THE LENS WAS FINAL LOADED USING THE LONG ANGLE FORCEPS. THEN THE INJECTOR PROBE KEPT PASSING OVER OR UNDER THE IOL WITHOUT ADVANCING IT. THE INJECTOR PLUNGER WAS SLIGHTLY BENT UP. THE LENS WAS INSPECTED AND THERE WERE NO SCRATCHES ON THE LENS. SO THEY ENLARGED THE CORNEAL INCISION TO ABOUT 6MM, AND MANUALLY DELIVERED THE LENS INTO THE ANTERIOR CHAMBER. THEN CLOSED THE INCISION WITH 3 INTERRUPTED 10-0 NYLON SUTURES.

  Patient problems: Eye Injury

  MAUDE report 16598450 ↗
• MalfunctionJan 12, 2022Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS LENS DAMAGED DURING ATTEMPTED IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234667 ↗