ACRYSOF® SN60WF (REF SN60WF.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380655093146), received between May 5, 2021 and Apr 10, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Material Twisted/Bent; Material Split, Cut or Torn

  A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) THAT HAD A DAMAGE OR CRACKS. NOTICED THAT ONE OF THE LENS HAPTICS APPEARED LONGER AND BENT AT AN UNUSUAL ANGLE. ADDITIONALLY, THERE WAS A CRACK IN THE LENS OPTIC WHEN THE PHYSICIAN EXAMINED IT UNDER THE MICROSCOPE. THE ISSUE WAS DETECTED DURING THE PROCEDURE, WHEN THE LENS WAS ABOUT TO BE LOADED INTO THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A DIFFERENT LENS. THE LENS DID NOT COME INTO CONTACT WITH THE PATIENT¿S EYE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839814 ↗
• MalfunctionDec 5, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED WITH A DESCRIPTION THAT THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23728723 ↗
• InjuryMar 20, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED IN THE CENTRAL PART IN DELIVERY SYSTEM. THE LENS WAS LEFT IMPLANTED IN THE PATIENT¿S EYE SO AS NOT TO LEAVE APHAKIA AND THIS GENERATED A POOR VISION IN THE PATIENT OF 20/800. ADDITIONAL INFORMATION RECEIVED STATING THAT IT WAS PLANNED TO EXPLANT THE LENS SINCE THE PATIENT DID NOT HAVE GOOD VISION.

  Patient problems: Visual Impairment

  MAUDE report 21653954 ↗
• MalfunctionJul 8, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS CRACKED WHEN IMPLANTED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19689968 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT UNABLE TO DRIVE AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 19212444 ↗
• InjuryApr 5, 2024Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) PROCEDURE, VISUALLY SIGNIFICANT OPACITY TO THE IOL MATERIAL ITSELF WAS NOTED. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN STATING HE SAW THE PATIENT AND THE DEPOSITS ON THE LEFT LENS WERE 98% BETTER. THERE WAS A FAINT HAZE ON THE IOL SURFACE, BUT PHYSICIAN DID NOT SEE THE ROUND DEPOSITS THAT HE HAD NOTED PREVIOUSLY. PATIENT WAS TREATED WITH CORTICOSTEROIDS FOR 1 MONTH, BUT PHYSICIAN DID NOT SEE HER AT THE SLIT LAMP SINCE THEN UNTIL REVIEW DAY. PHYSICIAN ASSESSED THE ISSUE TO BE INFLAMMATORY IN ORIGIN AND THE CORTICOSTEROIDS SOLVED IT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Insufficient Information

  MAUDE report 19050215 ↗
• InjuryMar 15, 2024Dent in Material; Dent in Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EDEMA IN CORNEA AND ALSO OBSERVED THAT THE LENS HAD STRIPES WHICH WAS INTERFERING WITH THE VISION AND THE LENS WAS PLANNED TO BE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 18912973 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENTS VISION WAS NOT CLEAR AND NOTES HAZY VISION LIKE A RAINY DAY. YAG LASER WAS PERFORMED HOWEVER WITH NO HELP. CONSUMER STATED THAT SHE WOKE UP IN THE MIDDLE OF PROCEDURE WITH PAIN. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17486020 ↗
• MalfunctionJun 27, 2022Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), CRACK IN LENS WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14826097 ↗
• MalfunctionMay 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PARTICLE WAS FOUND ON THE POSTERIOR SIDE OF THE LENS. THEY CANNOT SEE ANY PARTICLES IN THE CARTRIDGE WHEN THE LENS IS LOADED. THEY ALWAYS FIND THE PARTICLE FIRST WHEN THE LENS HAS BEEN INJECTED. THE SURGERY WAS COMPLETED BY REMOVING THE PARTICLE FROM THE LENS WHEN IT WAS IMPLANTED INTO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14331491 ↗
• MalfunctionMay 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PARTICLE WAS FOUND ON THE POSTERIOR SIDE OF THE LENS. THEY CANNOT SEE ANY PARTICLES IN THE CARTRIDGE WHEN THE LENS IS LOADED. THEY ALWAYS FIND THE PARTICLE FIRST WHEN THE LENS HAS BEEN INJECTED. THE SURGERY WAS COMPLETED BY REMOVING THE PARTICLE FROM THE LENS WHEN IT WAS IMPLANTED INTO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14331420 ↗
• MalfunctionApr 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE DURING THE DAY AND THE NIGHT VISION WAS VERY POOR. IT WAS VERY HARD TO SEE UNDER DIM LIGHTS AND WAS CONSIDERING A LENS EXCHANGE. ADDITIONAL INFORMATION WAS RECEIVED STATING SHE WAS SEEING GLISTENING'S BUT CANNOT TELL WHICH EYE IT WAS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14024769 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS PROVIDED THAT LENS WAS INSERTED INTO THE PATIENT THEN REMOVED TO DO CONVERTING INTO VITRECTOMY AS PATIENT WAS SQUEEZING. LENS WAS REMOVED DUE TO NOT ENOUGH CAPSULE TO HOLD THE LENS, AND WAS REPLACED WITH A SPECIAL LENS.

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

  MAUDE report 13107524 ↗
• MalfunctionJun 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A FACILITY REPRESENTATIVE REPORTED VIA A SAMPLE RETURN THAT THE "LENS HAD FROSTING ON IT" NOTED WHEN INSERTING IN EYE. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT WHEN THE LENS WAS IMPLANTED, THE SURGEON FELT IT WAS NOT CLEAR, HAD A HAZE, OPTED TO REMOVE THE IOL AND IMPLANT ANOTHER IOL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033505 ↗
• MalfunctionMay 5, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A SURGICAL TECHNICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL BEGAN TO DEPLOY THE IOL WAS NOT UNFOLDING CORRECTLY. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777977 ↗