ACRYSOF® SN60WF (REF SN60WF.125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380655095669), received between May 3, 2022 and Jul 25, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN VITRECTOMY PROCEDURE, LENS HAPTIC WAS BROKEN DURING DELIVERY OF IOL. LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE. PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22621048 ↗
• MalfunctionJan 8, 2024Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18463660 ↗
• MalfunctionJan 8, 2024Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, NOTICED IOL¿S APPEAR ON THE SLIT LAMP TO BE OPACIFYING CAUSING VISUAL ACUITY LOSS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 18463561 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE DISTANCE VISION BECAME LESS CLEAR SO MUCH SO THAT THE PRESCRIPTION NEEDED TO BE CHANGED WHICH NOTICEABLY CLEAR FOR DISTANCE IN THE BEGINNING. THE CONSUMER MENTIONED THAT SHE USED TO HAVE ONLY LITTLE BLACK LINES FOR FLOATERS, SINCE SURGERY IMMEDIATELY SHE WAS SEEING ¿GRAY CLOUDS¿ FLOATING BACK AND FORTH WITH MORE FREQUENCY, ALONG WITH THE ORIGINAL FLOATERS. THE FLOATERS SOMETIMES AFFECTED VISION WHILE DRIVING AND NIGHT DRIVING WAS STILL AN ISSUE AS THE GLARE FROM HEADLIGHTS WAS NO BETTER THAN IT WAS BEFORE WITH OR WITHOUT GLASSES. CONSUMER STATED THAT SHE HAD DROOPING OF THE RIGHT EYE AND IT HAS NOT GONE AWAY, VERY NOTICEABLE TO HER. RECENTLY SHE HAD RED AT THE BOTTOM LID OF RIGHT EYE, DOCTOR PRESCRIBED A DROP BUT SHE DID NOT USE AS SHE WAS AFRAID TO. CONSUMER ADDITIONALLY MENTIONED THAT RECENTLY GOT PRESCRIPTION SUNGLASSES FOR THE FIRST TIME AND SEEM TO BE WEARING THEM EVEN WHEN THE SUN WAS NOT SHINING AND WHEN DRIVING. NEVER HAD AN ISSUE WITH THIS BEFORE ALMOST LIKE SHE WAS SENSITIVE TO LIGHT, HER DISTANCE VISION WAS WORSE WHEN GLASSES WERE OFF AS SHE WAS ABLE TO WATCH TV IN BED AND READ THE GUIDE BU

  Patient problems: Blurred Vision; Ptosis; Visual Disturbances; Vitreous Floaters

  MAUDE report 16672112 ↗
• MalfunctionMay 23, 2022Material Twisted/Bent; Material Twisted/Bent

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS CRINKLED AFTER INSERTION AND TAKEN OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 14468794 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14264745 ↗