ACRYSOF® SA60AT (REF SA60AT.255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652555913), received between Mar 12, 2021 and Feb 2, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PHYSICIAN DISCOVERED THAT ONE OF ITS HAPTICS WAS BROKEN BEFORE LOADING THE LENS INTO THE INJECTOR.

  Patient problems: Insufficient Information

  MAUDE report 24242817 ↗
• MalfunctionDec 5, 2025Break; Scratched Material; Material Split, Cut or Torn; Break; Scratched Material; Material Split, Cut or Torn

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BROKEN HAPTICS AND SCRATCHED OPTICAL SURFACE WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23725429 ↗
• InjuryMar 28, 2024Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,DURING IMPLANTATION ONE HAPTIC WAS BROKEN. THE MAIN INCISION WAS ENLARGED TO 2.75, THE IOL CUT IN 2 WITH FORCEPS. THE IOL WAS REPLACED WITH A NEW IOL. NO MEDICAL/SURGICAL INNERVATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18993102 ↗
• MalfunctionOct 6, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT A PLUNGER CAUGHT THE LENS LEAVING IT IMPACTED INSIDE THE CARTRIDGE AND FRACTURED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED THE SAME DAY BY IMPLANTING ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885377 ↗
• MalfunctionDec 21, 2022Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  A NURSE REPORTED WITH A DESCRIPTION OF HAIR IN THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16021280 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING A INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CONTINUED TO HAVE PROBLEMS WITH SEEING HALOS. THE IOL WAS EXCHANGED FOR NON-MULTIFOCAL LENS APPROXIMATELY 2 YEARS AND 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE ISSUE HAS NOT BEEN RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE.

  Patient problems: Halo

  MAUDE report 12500464 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE GLARE, STREAKS OF LIGHT, HALOS, AND BLURRY VISION. THE IOL WAS EXCHANGED FOR A DIFFERENT COMPANY LENS AND LIMBAL RELAXATION INCISIONS WERE APPLIED. THE PATIENT WAS NOT HOSPITALIZED AND WAS DISCHARGED ON THE SAME DAY. POST OPERATION THE VISUAL ACUITY OF THE PATIENT WAS CLEAR BUT STILL HAD A STARBURSTS. THE PROGNOSIS WAS EXCELLENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12487467 ↗
• MalfunctionMar 12, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, A "LINE IN THE OPTIC ZONE" WAS OBSERVED. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476887 ↗