ACRYSOF® SN60WF (REF SN60WF.170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380655093139), received between Jul 15, 2021 and Dec 10, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHITE SPOTS APPEARED ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23767958 ↗
• MalfunctionMay 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED AND THEY NOTICED A CRACK IN THE LENS. SO, IT WAS THEN REMOVED AND A BACKUP LENS WAS INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22084659 ↗
• MalfunctionApr 10, 2023Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE LENS WAS USED BUT BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16709328 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING A INTRAOCULAR LENS IMPLANT PROCEDURE 2 YEARS AGO, SHE HAD BLURRY VISION AND DIPLOPIA. SHE APPROACHED A SPECIALIST AND THEY DID MUSCLE SURGERY ON HER AND CORRECTED THE DIPLOPIA. HOWEVER, HER VISION WAS STILL VERY BLURRY. SHE WENT TO ANOTHER SURGEON WHO DID A YAG ON HER WHICH HELPED SOME, BUT THERE IS STILL A BLURRY AREA IN HER VISION. SHE WENT TO ANOTHER SURGEON WHO STATES THAT SOMETHING HAD HAPPENED DURING SURGERY TO CAUSE THIS AND THE ONLY WAY TO FIX IT IS TO DO AN IOL EXCHANGE WHICH THEY WILL NOT DO DUE TO THE RISK OF BEING HER OTHER EYE IS LEGALLY BLIND. SHE HAS LOST HER JOB DUE TO HER VISION IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED WHICH STATES THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION REQUIRED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15297295 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD RESIDUAL 3.0D MYOPIA AFTER SURGERY WITH 17.0 DIOPTER LENS. IT WAS INITIALLY CONSIDERED TO BE PURELY THE PATIENT'S CONDITION. THE LENS WAS REPLACED WITH 14.0 AND THE POSTOPERATIVE RESIDUAL MYOPIA WAS CLOSE TO 0. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. NO MORE FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 14751950 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD RESIDUAL 3.0D MYOPIA AFTER SURGERY. THE LENS WAS STILL IN PATIENTS EYE. THE DOCTOR WAS CONCERNED THAT THE INFORMATION ON THE PRODUCT'S LABEL MIGHT BE INCORRECT. NO MORE FURTHER INFORMATION RECEIVED AND STATED THAT, THE IOL WAS REPLACED DURING A SECONDARY PROCEDURE WITH 14.0 DIOPTER.

  Patient problems: Visual Impairment

  MAUDE report 14751872 ↗
• MalfunctionJun 1, 2022Break; Failure to Advance; Break; Failure to Advance

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE IOL GOT STUCK IN THE CARTRIDGE WHEN ALREADY 3/4 OF THE IOL WAS IN THE ANTERIOR CHAMBER. THERE WAS A COMPLETE BREAK IN THE LOOP AT ITS BASE. THE LENS WAS THEN EXPLANTED IN THE SAME PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565135 ↗
• MalfunctionMar 2, 2022Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT DURING A INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHITE JELLY DEPOSITS ON LENS OPTIC AND HAPTIC WERE FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653055 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN OPHTHALMIC ASSISTANT REPORTED FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION FOUND A DISLOCATED LENS BAG COMPLEX WITH THE IOL SITTING ON THE RETINA. AS PER THE SURGEON THE DISLOCATION WAS DUE TO POOR SUPPORT WHICH WAS DUE TO PATIENT ANATOMY. ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS SUCH AS PARS PLANA VITRECTOMY, YAMANE INTRASCLERAL HAPTIC FIXATION OF THE IOL, AND LIMBAL RELAXATION INCISIONS WERE PERFORMED. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS. THE PATIENT PROGNOSIS WAS GOOD AND THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THERE WAS NO PATIENT HARM.

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

  MAUDE report 13008506 ↗
• MalfunctionAug 24, 2021Defective Device; Defective Device

  AN ACCOUNT MANAGER EMAILED ON BEHALF OF A FACILITY REPRESENTATIVE THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO "AN APPARENT DEFECT ON THE IOL". ADDITIONAL INFORMATION RECEIVED AND IT INDICATES THAT, THE LENS WAS OPENED/LOADED/ DEFECT WAS DISCOVERED PRIOR TO IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358478 ↗
• MalfunctionJul 15, 2021Break; Break

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED INDICATING THAT THE INTRAOCULAR LENS FOUND BROKEN WHEN OPENED.

  Patient problems: Insufficient Information

  MAUDE report 12176296 ↗