ACRYSOF® SA60WF (REF SA60WF.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652332736), received between Apr 1, 2021 and Apr 8, 2026 — classified as 4 injuries, 10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING LOADING, WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED REPLACEMENT LENS WITHOUT ANY HARM TO THE PATIENT. 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 24813464 ↗
• MalfunctionOct 17, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE HAPTIC PART OF THE LENS WAS DAMAGED. PROCEDURE COMPLETED SAME DAY, WITH NEW UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322111 ↗
• MalfunctionJul 12, 2025Break; Break

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, DAMAGE TO THE HAPTIC WAS OBSERVED AFTER THE LENS WAS PLACED IN THE POSTERIOR CAPSULE. DURING INSERTION, THE HAPTIC BECAME COMPLETELY DETACHED. THE LENS WAS SUBSEQUENTLY CUT INTO PIECES AND REMOVED, AND A NEW LENS WAS IMPLANTED. THE SURGERY TIME WAS EXTENDED, BUT THERE WAS NO ADDITIONAL IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22488259 ↗
• MalfunctionMay 13, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS IMPLANT PROCEDURE LEADING HAPTIC IS NOT FLEXIBLE, SURGEON TRIED TO LOAD 2 TIMES BUT CHOOSE NOT TO IMPLANT SINCE THE HAPTIC WAS NOT FLEXIBLE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010958 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT POSTERIOR CAPSULE RUPTURED WHEN DIALING THE LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. LENS WAS REPLACED WITH ANOTHER MODEL COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 20266122 ↗
• MalfunctionAug 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A MATERIALS MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE THERE WAS A PIECE OF PLASTIC ATTACHED TO THE IOL AND THE SURGEON TRIED TO TAKE IT OFF, BUT COULD NOT REMOVE. BOTH LEFT IN PLACE. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WAS NO PATIENT HARM INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225154 ↗
• MalfunctionJun 30, 2022Scratched Material; Scratched Material

  A NURSE REPORTED AFTER THE IOL WAS DELIVERED IN THE BAG, A VERY CLEARLY MARKING / A SCRATCH WAS OBSERVED IN THE MIDDLE OF THE LENS. THE LENS HAS BEEN CUT FOR REMOVAL FROM THE PATIENT¿S EYE. THE REPLACEMENT LENS WAS USED. NO PATIENT HARM REPORTED, SYMPTOMS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874862 ↗
• InjuryJun 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT A LENS WAS INSERTED AND REMOVED. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS COMPLETE ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14744392 ↗
• MalfunctionJun 9, 2022Defective Device; Defective Device

  TECHNICAL ASSISTANT REPORTED THAT THERE WAS A DAMAGED LENS IN THE STOCK.

  Patient problems: Insufficient Information

  MAUDE report 14642129 ↗
• MalfunctionMay 31, 2022Defective Device; Defective Device

  AN ADMINISTRATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WAS DAMAGED AND HAD TO BE CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14546435 ↗
• InjurySep 16, 2021Sharp Edges; Sharp Edges

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION, EDGE OF THE LEADING HAPTIC CUT THE POSTERIOR CAPSULE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DOCTOR FEELS THE LENS HAD A SHARP EDGE TO IT THAT TORE THE POSTERIOR CAPSULE. THE LENS REMAINS IN THE PATIENT'S EYE. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS EXPECTED ON THIS REPORT AS SURGEON WAS UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Capsular Bag Tear

  MAUDE report 12480844 ↗
• InjuryJun 18, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE INTRAOCULAR LENS WAS BROKEN (EARLIER REPORTED AS HAPTIC BROKEN) IN EYE AS THERE WAS A LOADING ISSUE (WRONG CARTRIDGE USED) AND WRONG PLACEMENT OF HAPTICS IN THE CARTRIDGE. THE INTRAOCULAR LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED.

  Patient problems: Eye Injury

  MAUDE report 12023597 ↗
• MalfunctionApr 8, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) WAS SCRATCHED UPON IMPLANTING. THE LENS AS REMOVED DURING THE INITIAL PROCEDURE AND A BACKUP LENS WAS IMPLANTED. THERE IS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636210 ↗
• MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE HAS REPORTED THAT DURING FIVE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, AND AFTER THE INSERTION OF THE IOL, DEBRIS WAS NOTED. THE DEBRIS WAS CLEARED FROM THE PATIENTS USING I/A. THE LENSES WERE CHECKED UNDER THE MICROSCOPE PRIOR TO INSERTION INTO THE EYE, AND NO DEBRIS COULD BE SEEN. ONLY AFTER IT WAS INSERTED INTO THE EYE COULD IT BE SEEN. THE ORIGINAL PROCEDURE WAS COMPLETED IN ALL INSTANCES AND JUST A FEW MINUTES OF EXTRA TIME WAS USED TO ENSURE THE DEBRIS HAD BEEN CLEARED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATE WITH THIS PHYSICIAN. THIS REPORT IS ASSOCIATED WITH IOL 1 OF 5.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602949 ↗