ACRYSOF® SA60AT (REF SA60AT.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652555876), received between Apr 16, 2021 and May 12, 2026 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE AND HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IT WAS NOTED DURING LOADING OF THE LENS BY THE SURGEON THERE WAS NO DIRECT CONTACT OF THE DAMAGED LENS WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150884 ↗
• MalfunctionAug 6, 2025Inaccurate Delivery; Inaccurate Delivery

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE INTRAOCULAR LENS WAS BEING POSITIONED IN THE AUTO SENSOR, IT WAS UNEXPECTEDLY AND FORCEFULLY EJECTED. THIS SUDDEN EJECTION RESULTED IN THE LOSS OF THE IOL, MADE IT UNUSABLE FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726869 ↗
• MalfunctionJun 27, 2025Break; Break

  A PHYSICIAN REPORTED THAT WHILE SHE WAS FOLDING A COMPANY LENS INTO COMPANY CARTRIDGE, THE LEADING HAPTIC BROKE SO SHE HAD TO USE ANOTHER IOL. THE ISSUE NOTED TO BE HAPPENED DURING OPENING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346244 ↗
• MalfunctionJun 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS WERE STUCK IN THE INJECTOR WHEN ADVANCING AND BROKEN AND PROCEDURE OR MANEUVER WAS STOPPED. LENS WAS REPLACED WITH ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336169 ↗
• MalfunctionApr 18, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN IN THE BAG WHILE IMPLANTING. THERE WAS NO INTERVENTION AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864478 ↗
• MalfunctionFeb 25, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A MECHANICAL FAILURE. THE LENS ENTERED OR TOUCHED THE PATIENT EYE AND A SECOND LENS WAS USED. THE EXCHANGED LENS WAS SAME AS THE IMPLANTED LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT DID NOT HAD IOL EXCHANGE. THERE WAS AN ISSUE WITH THE ORIGINAL LENS AND IT WAS REPLACED IN THE INITIAL PROCEDURE. THE EXACT MECHANICAL ISSUE WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21457819 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH VISION ISSUE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS VISION ISSUE AND NEW POWER NEEDED.

  Patient problems: Blurred Vision

  MAUDE report 21331998 ↗
• MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD DEFECTIVE HAPTIC AND LOOKED TO BE CRINKLED AND HAD SMUDGES ON IT. THE LENS WAS ATTEMPTED TO BE IMPLANTED BUT HAD NO CONTACT WITH PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303605 ↗
• MalfunctionNov 27, 2024Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DURING THE PROCEDURE, WHEN THE IOL WAS BEING INSERTED, IT TURNED OUT THAT THE LENS WAS DAMAGED, HAPTIC PART OF THE LENS WAS TORN OFF. THE IOL WAS NOT SUITABLE FOR IMPLANTATION, IT HAD TO BE REPLACED WITH A NEW ONE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795131 ↗
• MalfunctionJun 10, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED SCRATCHES IN THE OPTICAL AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19499262 ↗
• MalfunctionJun 4, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT THEY HAD A LINE/MARK ON THEIR LENS AFTER IMPLANT. HE USED LENS BUT IMPLANTED THROUGH A DIFFERENT CARTRIDGE, BUT IT SHOULD HAVE BEEN IMPLANTED THROUGH ANOTHER CARTRIDGE. NO PATIENT HARM, BUT LENS HAS A MARK IN THE MIDDLE OF IT. LENS WAS STILL IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460129 ↗
• MalfunctionMar 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF LENS WAS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18928679 ↗
• MalfunctionJun 13, 2023Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DAMAGED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17117416 ↗
• MalfunctionFeb 8, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO FURTHER INFORMATION TO PROVIDE AND THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. A BACK UP LENS WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16325152 ↗
• InjuryJan 9, 2023Material Opacification; Material Opacification

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE SENIOR ASSISTANT EDITOR STATING THE PATIENT HAS DIMINISHED QUALITY OF VISION. HE CANNOT SEE IF THE LIGHT COMES FROM THE FRONT SIDE. THE PATIENT'S LEFT EYE WAS ALREADY BLIND, AND NOW HE HAS COMPROMISED VISION IN THE RIGHT EYE TOO. THE PATIENT WAS QUITE DEPRESSED AND FRUSTRATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances; Visual Impairment

  MAUDE report 16127808 ↗
• InjuryApr 26, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENSES WERE SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Insufficient Information

  MAUDE report 14207759 ↗
• InjuryApr 26, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENSES WERE SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Insufficient Information

  MAUDE report 14206486 ↗
• MalfunctionFeb 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, A FISSURE WAS EVIDENT IN THE OPTICS OF THE LENS, THE SURGEON DECIDED NOT TO PERFORM THE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497652 ↗
• MalfunctionFeb 8, 2022Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE DEPLOYING THE LENS IN SAC IT IS OBSERVED THAT IT IS DETERIORATED IN THE OPTICS WITH 2 LINES, APPARENTLY PERPENDICULAR TO HAPTIC PERIPHERAL FRACTURES, ONE OF THEM PARTIALLY COMPOSES THE PUPILLARY AXIS. THE LENS SHIFTED. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL COMPLICATIONS. LENS EXTRACTION WAS PERFORMED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478072 ↗
• MalfunctionApr 16, 2021Defective Component; Defective Component

  A HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS 9IOL) IMPLANT WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11677714 ↗