ACRYSOF® SN60WF (REF SN60WF.120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380655095652), received between Jun 28, 2021 and Aug 3, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, LENS UNFOLDED IN EYE, AND THE PHYSICIAN NOTICED A CENTRAL CURVED CRACK IN THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17452145 ↗
• InjuryJul 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON RIGHT EVALUATION PCL PHACODONESIS, PRESENT SUBLUXED AND HANGED SUPERIOR NASAL. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17425049 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR ANOTHER MONOFOCAL LENS MODEL 4 YEARS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE REASON FOR EXPLANT WAS NOT MENTIONED BY THE REPORTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17150876 ↗
• MalfunctionJan 3, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC ON THE LENS DID NOT FOLD IN PROPERLY, WHEN SURGEON ATTEMPTED TO INSERT THE LENS IN THE EYE IT DID NOT ADVANCE CORRECTLY SO LENS WAS NOT COMPLETELY INSERTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16086895 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS LOOKING AT THE EYE CHART AND SAW A HAZY SPOT THAT DOES NOT MOVE, IT ALSO SEEMED AS THOUGH, SHE WAS LOOKING THROUGH A MESH NET AND VISION IS NOT AS CLEAR. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT HAD SWELLING IN MACULA AND DOCTOR HAD PRESCRIBED TWO WEEK COURSE OF STEROIDS. STILL THE PATIENT SWELLING DID NOT RESOLVED AND THE OTHER SYMPTOMS MIGHT BE BECAUSE OF SWELLING OF MACULA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Macular Edema; Visual Impairment; Vitreous Floaters

  MAUDE report 15318240 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT IS RECEIVED FROM THE HEALTH AUTHORITY AND STATED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED CONJUNCTIVAL HYPEREMIA AND CORNEAL EDEMA ON THE FIRST POSTOPERATIVE DAY. THE PHYSICIAN HAD PRESCRIBED UNSPECIFIED TOPICAL EYE DROPS. AFTER THREE DAYS OF PATIENT RE-EXAMINATION, CORNEAL EDEMA DECREASED SIGNIFICANTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Corneal Edema; Hyperemia

  MAUDE report 15291640 ↗
• MalfunctionJun 28, 2021Difficult to Fold, Unfold or Collapse; Failure to Unfold or Unwrap; Difficult to Fold, Unfold or Collapse; Failure to Unfold or Unwrap

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THERE WAS A LENS FOLDING ISSUE IN THE DELIVERY SYSTEM AND THE LENS WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12074648 ↗