ACRYSOF® SA60AT (REF SA60AT.320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380650141286), received between May 7, 2021 and May 26, 2025 — classified as 2 injuries, 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE PATIENT HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN 2021 AND THE PATIENT UNDERWENT SEMI-ANNUAL EXAMINATION, IT WAS DISCOVERED THAT A GLISTENING HAD FORMED. THE PATIENT WOULD LIKE INFORMATION ON WHETHER THIS IS NORMAL OR IF ANYTHING CAN BE DONE ABOUT IT. ADDITIONAL INFORMATION HAS RECEIVED IT STATED THAT THE PATIENT REPORTED THAT SHE WAS FIRST DIAGNOSED WITH GLISTENING IN (B)(6) 2025 DURING HER SIX-MONTHLY OPHTHALMOLOGIST APPOINTMENT. IN (B)(6) 2021, SHE HAD THE IOL IMPLANTED, AFTER SHE HAD AN IOL WITH AN INCORRECT DIOPTER IMPLANTED IN (B)(6) 2021 AND A TEAR IN THE IOL WAS ALSO DETECTED DURING THE OPERATION. SINCE HER RIGHT EYE HAS ALREADY BEEN OPERATED ON TWICE AND A SECONDARY CATARACT WAS ALSO LASERED AND THERE WERE ALSO SOME COMPLICATIONS DURING THE 2ND OPERATION, THE CHANGE IS CURRENTLY THE LAST POSSIBLE OPTION FOR HER. SHE WOULD JUST BE INTERESTED TO KNOW IF THERE ARE ANY TIPS ON HOW SHE CAN ACT TO PREVENT FURTHER PROGRESSION OR IF THERE IS ANY RESEARCH INTO WHETHER THE FORMATION OF MICROVACUOLES CAN BE STOPPED. SO FAR, SHE HAS MAINLY BEEN AFFECTED BY DRIVING IN THE DARK. ADDITIONAL INFORMATION HAS RECEIVED IT STATED THAT THE

  Patient problems: Visual Impairment

  MAUDE report 22083562 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL CONFUSION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS ANISOMETROPIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19664442 ↗
• MalfunctionMay 9, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19277093 ↗
• MalfunctionMay 7, 2021Defective Device; Defective Device

  A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE. NO PATIENT HARM WAS REPORTED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789414 ↗