ACRYSOF® SA60AT (REF SA60AT.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652555883), received between Mar 26, 2021 and Apr 10, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Defective Device” (6 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.

• MalfunctionApr 10, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PRIOR TO LOADING THE LENS INTO THE CARTRIDGE, IT WAS DISCOVERED THAT ONE OF THE HAPTIC LEGS WAS TWISTED. AS A RESULT, THE LENS COULD NOT BE USED. THE LENS WAS REPLACED WITH AN IDENTICAL MODEL, WHICH WAS SUCCESSFULLY IMPLANTED WITHOUT ANY COMPLAINTS OR COMPLICATIONS FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838967 ↗
• MalfunctionOct 15, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS MOUNTED INTO THE CARTRIDGE WITHOUT ANY ISSUES AND THEN INSERTED INTO THE COMPANY INJECTOR AND ADVANCED SMOOTHLY. THE LENS WAS INJECTED WITHOUT ANY COMPLICATIONS. HOWEVER, WHEN THE DOCTOR ROTATED LENS TO POSITION THE HAPTIC, IT WAS OBSERVED THAT THE HAPTIC WAS AMPUTATED. THE LENS WAS REPLACED WITH ANOTHER OF THE SAME DIOPTER. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT'S OUTCOME WAS RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 23277974 ↗
• MalfunctionAug 12, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, DURING THE LENS INJECTION PROCESS FOR THE IMPLANT, IT IS IDENTIFIED THAT THE HAPTIC GOT STUCK IN THE INJECTOR AND FRACTURES, WHICH WAS WHY THE LENS MUST BE REMOVED AND A NEW ASSEMBLY MUST BE PERFORMED TO COMPLETE THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

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

  MAUDE report 22780978 ↗
• MalfunctionJun 13, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFORMED IN THE CARTRIDGE AND COULD NOT BE USED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202352 ↗
• MalfunctionMay 22, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE PHYSICIAN WAS LOADING, THE LEADING HAPTIC WAS BROKE. THE SURGERY WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ADDITIONAL INFORMATION REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071704 ↗
• MalfunctionMay 19, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE INJECTOR AND BROKEN. THERE WAS NO PATIENT CONTACT AND HAM. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS WAS DAMAGED IN DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046443 ↗
• MalfunctionMay 8, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE INJECTOR AND BROKEN WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986870 ↗
• MalfunctionMar 17, 2025Product Quality Problem; Product Quality Problem

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21625837 ↗
• MalfunctionFeb 24, 2025Failure to Fold; Inaccurate Delivery; Failure to Fold; Inaccurate Delivery

  A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DIFFICULT TO FOLD AND DID NOT DELIVER PROPERLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21445078 ↗
• MalfunctionDec 31, 2024Device Damaged Prior to Use; Defective Device; Device Damaged Prior to Use; Defective Device

  ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE LENS HAD A PATIENT CONTACT AND SURGERY WAS COMPLETED ON THE SAME DAY.

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

  MAUDE report 21047493 ↗
• MalfunctionOct 24, 2024Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAD DAMAGED HAPTIC. LENS WAS EXPLANTED IN A INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520662 ↗
• MalfunctionApr 5, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19048866 ↗
• MalfunctionMar 4, 2024Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING SURGERY ONE INTRAOCULAR LENS GOT DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 18825178 ↗
• MalfunctionOct 13, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DAMAGED INTRAOCULAR LENS (IOL) NOTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931700 ↗
• MalfunctionSep 26, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS HAD RESISTANCE DURING MOVEMENT THROUGH THE CARTRIDGE AND AT THE TIME OF EXIT THE LENS WAS DAMAGED. THE LENS WAS THEN REMOVED. THE INJECTOR AND CARTRIDGE WILL BE CHANGED WHILE IMPLANTING THE NEW LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, NO ADDITIONAL HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816215 ↗
• MalfunctionMay 15, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) PROCEDURE, WHEN LENS WAS IMPLANTED A CRACK WAS NOTICED. AS PER SURGEON'S OPINION, DEFECT IN LENS OR CARTRIDGE OR INSERTER MIGHT BE CAUSE OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16928667 ↗
• MalfunctionApr 6, 2023Scratched Material; Scratched Material

  A REGISTERED NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON LENS AFTER IMPLANTED. USED LENS CUTTERS TO REMOVE AND REPLACE THE LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16691594 ↗
• InjuryApr 1, 2022Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THERE WERE 02 LENSES, ONE ON TOP OF THE OTHER, AND IT WAS NECESSARY TO EXPLANT ONE OF THEM. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WERE TWO IOLS IN THE CAPSULAR BAG. ALSO THERE WAS A PATIENT HARM ASSOCIATED WITH THE EVENT. THE PATIENT HAD DEVELOPED CORNEAL EDEMA. AS A RESULT THE PATIENT WAS HOSPITALIZED AND RECEIVED STEROID-BASED TREATMENT. THE SYMPTOM WAS CONTINUING.

  Patient problems: Corneal Edema

  MAUDE report 13976542 ↗
• MalfunctionApr 29, 2021Scratched Material; Scratched Material

  A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTICED A SCRATCH ON THE LENS AFTER IT WAS IMPLANTED. THE SURGEON REMOVED AND REPLACED THE LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746616 ↗
• MalfunctionMar 26, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL WAS DAMAGED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575658 ↗