ACRYSOF® SA60AT (REF SA60AT.310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380650141279), received between Sep 3, 2021 and Mar 25, 2026 — classified as 2 injuries, 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break

  A NURSE REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AMPUTATION OF THE ARTIFICIAL LENS HAPTIC WAS OBSERVED DURING IMPLANTATION INTO THE LENS CAPSULE. THERE HAD BEEN NO IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684568 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED FOR MONOFOCAL IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IN SURGEON OPINION THE PRODUCT CONTRIBUTED TO THE EVENT.

  Patient problems: Blurred Vision

  MAUDE report 24003574 ↗
• MalfunctionSep 16, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED WHEN INSERTING THE LENS THAT THE HAPTIC TORE OFF THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066466 ↗
• MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON LOADING THE HAPTIC WAS TRAILING. THE LENS WAS UNABLE TO IMPLANT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING DURING FOLDING LENS INTO CARTRIDGE, THE TRAILING HAPTIC DID NOT FOLD PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318771 ↗
• MalfunctionJan 10, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS LEG HAPTIC WAS TWISTED AND THE PROCEDURE WAS COMPLETED ON SAME DAY USING ANOTHER REPLACEMENT LENS.

  Patient problems: Insufficient Information

  MAUDE report 21123230 ↗
• MalfunctionJan 9, 2025Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  A HEALTH CARE PROFESSIONAL REPORTED THAT LENS DID NOT UNFOLD AND HAPTICS ADHERENT TO OPTIC THEN IT WAS FREED UNDER VISCOELASTIC WITH CHOPPER AND SINKSI HOOK. LENS REMAINS INSIDE THE PATIENTS¿ EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21110101 ↗
• MalfunctionFeb 23, 2024Failure to Advance; Failure to Advance

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT ADVANCE THROUGH THE CARTRIDGE. THE PLUNGER OF THE BLUE HANDPIECE ENDED UP GOING OVER THE LENS. THE SURGEON ASKED FOR A NEW LENS. THERE WAS PATIENT CONTACT, HOWEVER NO HARM WAS DONE TO THE PATIENT. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765517 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DISTANCE VISUAL ACUITY (DVA) WAS 20/100. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. STILL PATIENT HAS SOME RESIDUAL SWELLING AND THE SURGEON IS EXPECTING THINGS TO CLEAR UP AND HER VISION TO BE LESS BLURRY.

  Patient problems: Blurred Vision; Inflammation; Visual Impairment

  MAUDE report 18612016 ↗
• MalfunctionFeb 15, 2022Failure to Advance; Failure to Advance

  A HEALTH PROFESSIONAL REPORTED THAT, THE LENS FOUND TO BE FAULTY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT DURING PHACOEMULSIFICATION WITH INTRAOCULAR IMPLANT PROCEDURE LENS LOADED UNTO CARTRIDGE, ADVANCED BUT WAS NOT ENGAGING WITH THE COMPANY INJECTOR. RELOADED BOTH BY SURGEON AND SCRUB NURSE, LENS ENGAGED BUT GOT STUCK AT THE TIP OF THE CARTRIDGE WHILST IMPLANTING IN THE EYE. THE PROCEDURE WAS COMPLETED WITH BACK-UP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534977 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  A NURSE REPORTED THAT DURING AN IOL IMPLANT PROCEDURE THE SURGEON OBSERVED THE LENS WAS FRACTURED FOR WHICH IT WAS NECESSARY TO REMOVE AND CHANGE THE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421437 ↗