ACRYSOF® SA60AT (REF SA60AT.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652555777), received between Jul 9, 2021 and Jan 23, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, LENS WAS FOUND TO HAVE SCRATCH AND THE LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24161603 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS HAPTIC FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922440 ↗
• MalfunctionAug 7, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A SURGEON REPORTED THAT DURING A CATARACT SURGERY AND INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND DEFORMED INSIDE THE COMPANY'S CARTRIDGE. THERE WAS NO CONTACT WITH THE PATIENT, AND THE LENS WAS NOT USED. THE ISSUE WAS IDENTIFIED AFTER THE PRODUCT WAS OPENED. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION RELATED TO THIS COMPLAINT. ACCORDING TO THE SURGEON, THE PATIENT WAS NOT IMPACTED OR HARMED DUE TO THE DEVICE'S PERFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740008 ↗
• MalfunctionJun 19, 2025Inaccurate Delivery; Inaccurate Delivery

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS NOT DISPENSE PROPERLY AND DESTROYED. THERE WAS NO SAMPLE AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22291655 ↗
• MalfunctionJan 7, 2025Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC FELL OFF IN THE EYE. IOL WAS REMOVED FROM THE EYE, ANOTHER IOL WAS USED BUT IT WAS INSERTED WITH THE SAME CARTRIDGE AS THE FIRST ONE. IN THE OTHER IOL HAPTIC ALSO FELL OFF. THE THIRD IOL WAS IMPLANTED WITH ANOTHER CARTRIDGE AND IT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091668 ↗
• MalfunctionJan 7, 2025Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC FELL OFF IN THE EYE. IOL WAS REMOVED FROM THE EYE, ANOTHER IOL WAS USED BUT IT WAS INSERTED WITH THE SAME CARTRIDGE AS THE FIRST ONE. IN THE OTHER IOL HAPTIC ALSO FELL OFF. THE THIRD IOL WAS IMPLANTED WITH ANOTHER CARTRIDGE AND IT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091661 ↗
• MalfunctionMay 22, 2024Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IMPLANTED LENS WAS DISCOLORED. THE PATIENT'S VISUAL ACUITY WAS ALSO IMPAIRED; OS CC 0.8. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 19371067 ↗
• MalfunctionFeb 12, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED AND NO PATIENT CONTACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18684837 ↗
• MalfunctionNov 19, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE AT THE MOMENT OF IMPLANTING THE LENS, A LINE WAS VISUALIZED IN THE PERIPHERAL AREA OF THE LENS UNDER THE MICROSCOPE AND REMOVED THE OBSERVED LENS FROM THE EYE AND RE-INSERT ANOTHER LENS OF THE SAME MODEL. THE PATIENT PRESENTED INCREASED OCULAR PRESSURE, WHICH WAS CONTROLLED AND, IN THE END, THE IOL WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED REGARDING CONMED AND THE PATIENT SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830836 ↗
• MalfunctionOct 12, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) FIBROUS TISSUE (LOOKING LIKE A SCRATCH ON THE POSTERIOR OPTIC) APPEARED AFTER THE IOL IMPLANTATION. THE SURGERY WAS COMPLETED THE SAME DAY. NO INFORMATION ABOUT LENS REMOVAL OR REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585549 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), RUPTURE OF THE CAPSULE BY THE LENS WAS NOTED. DUE TO UNSTABILITY OF THE LENS WITH THE HAPTICS, THE LENS WAS EXPLANTED AND REPLACED BY 3 PIECE LENS.

  Patient problems: Capsular Bag Tear

  MAUDE report 15368747 ↗
• MalfunctionOct 22, 2021Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF THE IMPLANT (IOL), THE LENS WAS WHITENING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685368 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT ON (B)(6) 2021 SURGEON DID THE CATARACT PROCEDURE WITH IOL. PER SURGEON ON (B)(6) 2021 SAW INFECTION AND REFERRED TO VR SURGEON FOR FURTHER INVESTIGATION AND TREATMENT. DUE TO SERIOUS LEVEL OF INFECTION ON (B)(6) 2021, VR SURGEON EXPLANT THE IOL ON (B)(6) 2021 AND PATIENT LOST VISION.

  Patient problems: Fungal Infection; Loss of Vision

  MAUDE report 12141978 ↗