ACRYSOF® SN60WF (REF SN60WF.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380655093122), received between Aug 11, 2021 and Feb 12, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  A BIOMEDICAL ENGINEER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ACCORDING TO THE TECHNOVIGILANCE REPORT, AN INCIDENT WAS IDENTIFIED RELATED TO THE INTRAOCULAR LENS, INDICATING POSSIBLE QUALITY DEFECTS. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, DURING LENS ROTATION, A COMPLETE LENS AMPUTATION WAS OBSERVED WITHIN THE CAPSULAR BAG. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322090 ↗
• MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION THAT, THERE WAS A FAILURE PLACEMENT, THE LENS GOT STUCK.

  Patient problems: Insufficient Information

  MAUDE report 21934634 ↗
• InjuryApr 5, 2024Material Opacification; Device Dislodged or Dislocated; Material Opacification; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) PROCEDURE, VISUALLY SIGNIFICANT OPACITY TO THE IOL MATERIAL ITSELF WAS NOTED. THE PATIENT DEVELOPED UGH(UVEITIS GLAUCOMA HYPHEMA) SYNDROME WHICH THE HAPTIC POKED THROUGH THE IRIS. THE LENS WAS EXPLANTED AND PATIENT WAS LEFT APHAKIC. PHYSICIAN SENT THE EXPLANTED LENS TO AN OPHTHALMIC PATHOLOGIST WHO WAS UNABLE TO DETERMINE ANYTHING FROM THE LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: UGH (Uveitis Glaucoma Hyphema) Syndrome

  MAUDE report 19050033 ↗
• InjurySep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DISLOCATED OUT OF THE BAG. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 9 YEARS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 17815803 ↗
• MalfunctionJun 28, 2022Crack; Crack

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS REMOVED FROM THE EYE DUE TO CRACK OBSERVED IN LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14840730 ↗
• MalfunctionMar 15, 2022Break; Failure to Advance; Break; Failure to Advance

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL DID NOT SLIDE COMPLETELY AND IT REMAINED STUCK IN THE CARTRIDGE, THE IOL PRESENTED WITH A HAPTIC FISSURE.

  Patient problems: Insufficient Information

  MAUDE report 13773709 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HA SYSTEM, THAT A PATIENT HAD BLURRED VISION IN THE LEFT EYE. THE PATIENT UNDERWENT CATARACT EXTRACTION WITH AN INTRAOCULAR LENS IMPLANT PROCEDURE AND EXPERIENCED INFLAMMATORY REACTION. TREATMENT RECEIVED WITH EYE DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation

  MAUDE report 13391586 ↗
• MalfunctionJan 7, 2022Failure to Fold; Appropriate Device Problem Term/Code Not Available; Failure to Fold; Appropriate Device Problem Term/Code Not Available

  A NON- HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT FOLD AND WAS UNABLE TO LOAD. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT LENS WAS UNABLE TO LOAD INTO CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190947 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOUR DAYS FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED CONJUNCTIVAL INFLAMMATION, CORNEAL EDEMA, AQUEOUS CELL, PAIN AND DECREASED VISION. THERE WAS NO AQUEOUS FIBRIN AND NO HYPOPYON. THE PATIENT WAS DIAGNOSED WITH STERILE ENDOPHTHALMITIS. POST OPERATION STEROIDS AND ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT. A TAP/INJECTION OF ANTIBIOTICS WAS PERFORMED. THERE WAS NO GROWTH FROM THE CULTURES. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FACILITY. THIS REPORT IS THE SECOND OF THREE REPORTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Endophthalmitis; Eye Pain; Inflammation

  MAUDE report 12540104 ↗
• MalfunctionAug 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, GLISTENINGS WERE OBSERVED ON THE IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309173 ↗