ACRYSOF® SA60WF (REF SA60WF.255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652332774), received between Nov 11, 2021 and Jul 7, 2025 — classified as 1 injury, 6 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN BEFORE IMPLANTATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER UNSPECIFIED LENS. THERE WAS NO IMPACT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412959 ↗
• InjuryAug 6, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NURSE LOAD IOL INTO CARTRIDGE AND INJECTOR BUT DID NOT OBSERVED LENS BEFORE. THEN PASS TO SURGEON FOR IMPLANTATION. THIS WAS COMMON PRACTICE OF THE SITE AND NO PRIOR EVENT LIKE THIS. SURGEON NOTICED VACUOLE-LIKE AND SCRATCH MARK ON THE LENS AFTER LOADING INTO PATIENT¿S EYES AND HAD TO CUT THE LENS TO EXTRACT IT OUT IN THE SAME OPERATION. BUT HAD TO WIDEN THE CUT MARK TO REMOVE THE PIECES OF LENS OUT. A NEW IOL REPLACED IN THE SAME OPERATION BUT TOOK LONGER TIME TO FINISH AND AS A RESULT WOUND WAS WIDEN THAN USUAL HAD TO STITCH THE WOUND CLOSE. PATIENT HAD INFLAMMATION AND ANTIBIOTICS WAS GIVEN AFTER THE SURGERY AND DOES NOT REQUIRE ADDITIONAL HOSPITAL STAY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.

  Patient problems: Eye Injury; Inflammation

  MAUDE report 19919179 ↗
• MalfunctionFeb 9, 2024Defective Device; Defective Device

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THE LENS AS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18674979 ↗
• MalfunctionSep 27, 2023Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE BODY OF THE LENS HAD SCRATCH APPROXIMATELY 1-2MM FROM THE EDGE. THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE AND THE SURGEON DID NOT REMOVE THE IMPLANTED LENS.

  Patient problems: Insufficient Information

  MAUDE report 17823729 ↗
• MalfunctionJan 2, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LINE WAS ONLY DETECTED UNDER THE MICROSCOPE AFTER THE IMPLANTATION OF IOL. THE IOL WAS NOT EXPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082312 ↗
• MalfunctionApr 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT LOAD PROPERLY. ADDITIONAL INFORMATION RECEIVED ON 31MAR2022, STATED THAT THERE IS A PATIENT CONTACT AND A POSSIBLE INJECTOR ISSUE. THE REPLACEMENT IOL WAS USED AND THERE WAS NO PATIENT HARM, THE ISSUE WAS RESOLVED, AND PATIENT WAS NO HOSPITALIZED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191634 ↗
• MalfunctionNov 11, 2021Defective Device; Failure to Eject; Defective Device; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT LOAD PROPERLY. ADDITIONAL INFORMATION WAS PROVIDED STATED THAT LENS WAS STUCK IN THE CARTRIDGE AND POSSIBLE INJECTOR ISSUE, IT WAS UNSURE IF IT WAS THE LENS, CARTRIDGE OR THE INJECTOR WAS BEING USED THERE WAS NO PATIENT HARM AND THE SURGEON PROGNOSIS WAS GOOD. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796628 ↗