ACRYSOF® SN60WF (REF SN60WF.135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380655095683), received between Jan 20, 2022 and Nov 8, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Defective Component; Defective Component

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY HAPTIC, NOT IMPLANTED. THE SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER LENS ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641778 ↗
• MalfunctionJul 13, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS DID NOT COME OUT OF THE CARTRIDGE. THE LENS CAME OUT WITHOUT A HAPTIC LATER ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17315407 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED ENDOPHTHALMITIS DUE TO FUNGUS, WHICH HAS ONLY GROWN ON THE LENS. ANTI FUNGAL MEDICATION WERE GIVEN. URGENT VITRECTOMY WAS PERFORMED. VISUAL ACUITY WAS IMPROVED TO 20/30, BUT INFLAMMATION PERSISTS IN THE ANTERIOR CHAMBER. THE PATIENT WAS UNDER MEDICATIONS. STARTS LOWERING AV TO 20/100. PERFORMED POSTERIOR CAVITY LAVAGE, IOL LAVAGE AND CAPSULES WITH URGENT POVIDONE-IODINE SOLUTION. LENS WAS EXPLANTED. THE PATIENT SYMPTOMS WERE IMPROVING. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED CONMED DETAILS.

  Patient problems: Endophthalmitis

  MAUDE report 15969599 ↗
• InjurySep 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PATIENT REPORTED THAT THERE WAS A SURGERY TO REPLACE THE LENS. THE SURGERY WAS DIFFICULT, AND IT TOOK 40 MINUTES. FOLLOWING THE IOL IMPLANT PROCEDURE, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) SOMETIMES RAISES TO 30, BLACK FLIES SWIM IN THE EYE AROUND THE LUMINOUS OBJECTS OF THE AREOLA. A PRELIMINARY DIAGNOSIS WAS GLAUCOMA. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT HAS FOGGY VISION. THE SUTURE WAS PLACED DURING THE SURGERY BUT THE PATIENT WAS NOT KNOWN THE REASON FOR SUTURE.

  Patient problems: Blurred Vision; Glaucoma

  MAUDE report 15474677 ↗
• InjuryJan 20, 2022Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS CASE WAS LOOSEN UPON OPEN UP, LENS WAS NOT SITTING AT THE CORRECT POSITION. LENS WAS INJECTED INTO THE EYE ANTERIOR CHAMBER AND FOUND THAT HAPTIC WAS MISSING. THE MISSING HAPTIC COULD NOT BE FOUND NEITHER IN THE EYE OR IN THE CARTRIDGE. PHYSICIAN DECIDED TO ENLARGE TO WOUND AND EXPLANTED THE LENS FROM THE EYE AND ANOTHER LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 13307913 ↗