ACRYSOF® SA60WF (REF SA60WF.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652332729), received between Mar 19, 2021 and Sep 18, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. 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 18, 2026Material Twisted/Bent

  A healthcare professional reported with a description of the haptic became attached to the tip of the injector and subsequently detached.Additional information has been received and stated that noticed the issue when the lens was inside the cartridge and about to insert into patient's eye. The trailing haptic was stuck. Procedure complete on the same day with backup lens.

  Patient problems: Insufficient Information

  MAUDE report 50818472 ↗
• MalfunctionMay 5, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD RIFT AFTER INSERTION. THE LENS WAS INSPECTED BEFORE LOADING, AND THE SAME NURSE LOADED IT AS PER USUAL PRACTICE, USING THE SAME VISCOELASTIC AND THE SAME TYPE OF CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEAR MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENS. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. THE COMPANY CARTRIDGE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 25080366 ↗
• MalfunctionJul 14, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHILE INSERTING THE IOL INTO THE POSTERIOR CAPSULE, THE TRAILING HAPTIC CAME OUT TWISTED AND BROKEN INSIDE THE PATIENT¿S EYE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22492370 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH A DESCRIPTION OF THE OPTICAL PART WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 21890991 ↗
• MalfunctionNov 12, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGED BY INJECTOR OR SCRATCHED IOL AND NOTICED AFTER PLACEMENT IN EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20665338 ↗
• InjuryAug 8, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NURSE LOAD IOL INTO CARTRIDGE AND INJECTOR BUT DID NOT OBSERVED LENS BEFORE. THEN PASS TO SURGEON FOR IMPLANTATION. THIS WAS COMMON PRACTICE OF THE SITE AND NO PRIOR EVENT LIKE THIS. SURGEON NOTICED VACUOLE-LIKE AND SCRATCH MARK ON THE LENS AFTER LOADING INTO PATIENT¿S EYES AND HAD TO CUT THE LENS TO EXTRACT IT OUT IN THE SAME OPERATION. BUT HAD TO WIDEN THE CUT MARK TO REMOVE THE PIECES OF LENS OUT. A NEW IOL REPLACED IN THE SAME OPERATION BUT TOOK LONGER TIME TO FINISH AND AS A RESULT WOUND WAS WIDEN THAN USUAL HAD TO STITCH THE WOUND CLOSE. PATIENT HAD INFLAMMATION AND ANTIBIOTICS WAS GIVEN AFTER THE SURGERY AND DOES NOT REQUIRE ADDITIONAL HOSPITAL STAY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

  Patient problems: Eye Injury; Inflammation

  MAUDE report 19936557 ↗
• MalfunctionJun 3, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), NOTICED THAT LENS HAD A FOLD/MARK IN THE OPTICS. THEREFORE THE LENS WAS REPLACED WITH A NEW LENS DURING INITIAL PROCEDURE. NO PATIENT HARM REPORTED AND SYMPTOMS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447483 ↗
• MalfunctionMay 24, 2024Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,LENS BREAKAGE DURING IMPLANTATION.OPERATION WAS COMPLETED WITH BACK UP LENS USED.THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390788 ↗
• MalfunctionSep 18, 2022Break; Failure to Advance; Break; Failure to Advance

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC STUCK IN THE INTRODUCER AND BROKE OFF DURING LENS PLACEMENT. THE LENS WAS REMOVED AND A NEW IMPLANT INSERTED. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15443360 ↗
• MalfunctionJul 28, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS FOUND THAT LENS HAS MARK ON IT. THE LENS HAS BEEN REPLACED WITH THE SAME MODEL LENS. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119637 ↗
• MalfunctionJun 30, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A VERY CLEAR MARK OR SCRATCH WAS OBSERVED IN THE MIDDLE OF THE LENS AFTER THE IOL WAS DELIVERED IN THE BAG. THE LENS HAS BEEN CUT FOR REMOVAL FROM THE PATIENT¿S EYE. THE REPLACEMENT LENS WAS USED AND THE SURGERY WAS COMPLETED. THERE WAS PATIENT CONTACT WITH THE PRODUCT BUT NO PATIENT HARM WAS REPORTED. THE PATIENT'S SYMPTOMS WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877608 ↗
• InjuryNov 24, 2021Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND OUT TO BE SCRATCHED AFTER IMPLANTATION. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SCRATCH WAS NOTED AT THE CENTER OF THE LENS. ENLARGEMENT OF INCISION WAS REQUIRED TO REMOVED LENS DURING THE INITIAL PROCEDURE.

  Patient problems: Eye Injury

  MAUDE report 12868520 ↗
• MalfunctionOct 28, 2021Contamination; Contamination

  A NURSE REPORTED DURING A CATARACT EXTRACTION PROCEDURE WITH AN IOL, THE SURGEON FOUND A WHITISH FRAGMENT UPON INSERTION OF THE LENS ON THE PATIENT'S RIGHT EYE. THE RESIDUAL FRAGMENT WAS REMOVED WITHOUT ANY COMPLICATIONS FROM THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711921 ↗
• MalfunctionOct 6, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN IOL IMPLANT PROCEDURE, THE LENS WOULD NOT UNFOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585223 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEY HAVE PATIENT'S THAT HAVE EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). A COMPLETED QUESTIONNAIRE WAS RECEIVED INDICATING THE PATIENT RECEIVED MEDICAL TREATMENT IN THE RIGHT EYE OF A ADRENOCORTICAL STEROID INJECTION. AN ANTIBIOTIC, STEROID AND NON-STEROIDAL WERE ADMINISTERED TO THE PATIENT. THIS IS THE FIRST OF SIX (6) REPORTS FROM THIS FACILITY.

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

  MAUDE report 11832687 ↗
• 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 PATIENT 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 4 OF 5.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602951 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF AN INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED DURING A SECONDARY PROCEDURE DUE TO THE UNEXPECTED OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11530813 ↗