ACRYSOF® SA60WF (REF SA60WF.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652332743), received between Jul 28, 2021 and May 6, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED TEARS. 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 TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN PATIENT EYE.

  Patient problems: Insufficient Information

  MAUDE report 25095537 ↗
• MalfunctionMar 10, 2026Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE CARTRIDGE. UNFORTUNATELY, DURING THE ATTEMPT TO IMPLANT IT, THE LENS WOULD NOT COME OUT OF THE INJECTOR. A SECOND ATTEMPT WAS MADE, BUT IT WAS ALSO UNSUCCESSFUL. A NEW LENS WAS THEN PLACED INTO THE SAME CARTRIDGE, AND THIS ONE WAS SUCCESSFULLY IMPLANTED INTO THE EYE. 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 24559317 ↗
• MalfunctionMay 30, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, BEFORE THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS OPTIC FOUND TO BE DAMAGED. THERE WAS NO PATIENT CONTACT TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112668 ↗
• MalfunctionJan 5, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON IMPLANTED THE LENS THROUGH COMPANY INJECTION SYSTEM AFTER WHICH HE FOUND A SCRATCH IN THE OPTIC OF THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SURGEON DECIDED NOT TO REMOVE LENS, STILL REMAINED IN PATIENT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451589 ↗
• MalfunctionAug 22, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL REPORTED DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS DID NOT UNFOLD PROPERTY. THERE WAS PATIENT CONTACT BUT NO PATIENT IMPACT. THE SURGERY WAS COMPLETED WITH NEW MEDICAL DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595636 ↗
• MalfunctionNov 12, 2022Defective Device; Defective Device

  THE LENS WAS LEFT IN THE EYE, DECISION TAKEN BY SURGEON AND PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15785645 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE, HALOS, AND STREAKS IN HER VISUAL ACUITY WHICH WAS NOTICED THREE WEEKS AFTER IOL IMPLANTATION, PATIENT ALSO HAD YAG LASER WHICH MADE WORSE, IN DOCTOR DIAGNOSIS IT WAS NOTICED THAT PATIENT HAD A POSITIVE DYSPHOTOPSIA, SOME OF IT DUE TO THE LENS, SOME OF IT DUE TO THE DINGS FROM THE LASER AND SOME OF IT FROM VITREOUS OPACITIES, THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE, PATIENT ALSO HAD PARS PLANA VITRECTOMY AND LIMBAL RELAXATION INCISIONS. THERE WAS NO PATIENT HARM, THE PATIENT¿S ISSUE WAS RESOLVED AND THE SURGEON PROGNOSIS WAS EXCELLENT. THE PATIENT WAS NOT HOSPITALIZED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15335989 ↗
• MalfunctionApr 22, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND A STRING ON THE THREE LENSES. THE FACILITY HAS COLLECTED THE ONE STRING IN A JAR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE DAMAGED OPTIC WAS FOUND DURING PLACEMENT OF LENS AND LATER IT TURNS OUT TO BE A STRING WHICH COULD NOT BE REMOVED FROM THE OPTICS DURING INITIAL PROCEDURE. THE STRING WAS SCRAPED OFF THE OPTIC WITH A SWEEP. THE LENS REMAINS IMPLANTED IN THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 14187370 ↗
• MalfunctionMar 31, 2022Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WOULD NOT INJECT IN EYE CORRECTLY AND THE LENS WAS NOT FOLDING IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13967148 ↗
• InjuryFeb 14, 2022Defective Device; Defective Device

  A PURCHASING PERSON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS OPEN BUT NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT DEFECTIVE HAPTIC AND THE INCISION NEEDED TO BE ENLARGED AND THE LENS HAD ALREADY BEEN LOADED AND HALFWAY THROUGH INJECTOR WHEN REMOVED. ASKED FOR A NEW LENS. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.

  Patient problems: Eye Injury

  MAUDE report 13522093 ↗
• MalfunctionJul 28, 2021Failure to Advance; Failure to Advance

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL DID NOT ADVANCE CORRECTLY. THERE WAS PATIENT CONTACT WITH THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239804 ↗