ACRYSOF® SA60AT (REF SA60AT.245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652555890), received between May 24, 2021 and Sep 4, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break; Failure to Deliver

  A non healthcare professional reported that during an intraocular lens implantation surgery the lens haptic gets stuck in the injector, causing the haptic to break when the injector was retracted.Surgery was completed on the same day by using the replacement lens.

  Patient problems: Insufficient Information

  MAUDE report 50614435 ↗
• MalfunctionAug 27, 2026Material Split, Cut or Torn

  A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed part of the lens broke and would not deploy, deemed defective. The lens was explanted during initial procedure. The procedure was completed on same day by using another lens with same diopter and model. Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474927 ↗
• MalfunctionMar 6, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) BRACKET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE HAPTIC BROKE INSIDE THE SHOOTER BEFORE IMPLANTATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528210 ↗
• InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT DEVELOPED VITRITIS WITHIN THE FIRST WEEK AFTER SURGERY. AFTER A MONTH OF TREATMENT, THE INFLAMMATION RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 23451865 ↗
• MalfunctionMay 15, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL FOUND TO BE FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22026445 ↗
• MalfunctionApr 17, 2025Break; Break

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN IN THE BAG WHILE IMPLANTING LENS. 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 21853799 ↗
• MalfunctionMar 31, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS MOUNTED ON A CARTRIDGE. WHEN THE INJECTOR WITH THE CARTRIDGE WAS INSERTED INTO THE PATIENTS EYE, RESISTANCE WAS NOTED WHEN ENTERING THE CHAMBER AND WHEN THE LENS COMES OUT IT WAS SEEN TO BE BROKEN. ANOTHER LENS OF THE SAME DIOPTER WAS REQUESTED AND WHEN ASSEMBLING IT AGAIN, THE LENS MOUNTED ON THE SAME CARTRIDGE WAS FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM AND PATIENT WAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730548 ↗
• MalfunctionMar 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS MOUNTED ON A CARTRIDGE. WHEN THE INJECTOR WITH THE CARTRIDGE WAS INSERTED INTO THE PATIENTS EYE, RESISTANCE WAS NOTED WHEN ENTERING THE CHAMBER AND WHEN THE LENS COMES OUT IT WAS SEEN TO BE BROKEN. ANOTHER LENS OF THE SAME DIOPTER WAS REQUESTED AND WHEN ASSEMBLING IT AGAIN, THE LENS MOUNTED ON THE SAME CARTRIDGE WAS FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM AND PATIENT WAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730546 ↗
• MalfunctionMar 26, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DEFECTIVE/STIFF. THE HAPTIC WAS DEFORMED OR ASYMMETRIC. THERE WAS ALSO LENS LOADING DIFFICULTIES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700815 ↗
• MalfunctionNov 22, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCHED. THE PROCEDURE WAS COMPLETED SAME DAY WITH ANOTHER IOL.THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761078 ↗
• MalfunctionFeb 19, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF IOL BROKE OFF IN THE INJECTOR. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730297 ↗
• MalfunctionSep 20, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782047 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POSTERIOR CAPSULE RUPTURE WAS NOTED. HENCE THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 16896638 ↗
• MalfunctionFeb 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE OR WHITE THREADS STUCK TO THE IOLS. ATTEMPTS WERE MADE TO POLISH AWAY THE THREAD. THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR SEVEN OF SEVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364223 ↗
• MalfunctionFeb 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT COMPLICATIONS. THERE IS NO PLAN TO EXPLANT THE LENS. THE OBSERVED THREADS COULD NOT BE ISOLATED AND ARE NOT AVAILABLE FOR RETURN. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR FIVE OF SEVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364217 ↗
• MalfunctionAug 9, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR NOTED THAT THE LENS HAD SCRATCHED OPTIC, PRESENTS A LINE, THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15190065 ↗
• MalfunctionMay 24, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A SCRATCH WAS OBSERVED UNDER A MICROSCOPE. THE LENS WAS CUT AND REMOVED DURING THE INITIAL PROCEDURE AND SURGERY WAS COMPLETED WITH NO ISSUES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869868 ↗