ACRYSOF® SN60WF (REF SN60WF.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380655093245), received between Mar 2, 2021 and Feb 6, 2026 — classified as 10 injuries, 19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AN INTRAOCULAR LENS HAD BEEN USED AND WAS FOUND TO BE DAMAGED. ONE OF THE HAPTICS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT AND IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277138 ↗
• MalfunctionMar 18, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE IMPLANT WAS FOLDED INTO THE CARTRIDGE, IT FROZE AND HARDENED ON CONTACT WITH VISCOUS SOLUTION. IT WAS NOT POSSIBLE TO FOLD IT INTO THE CARTRIDGE. THE PROCEDURE WAS COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL. THE HARDENED IMPLANT WAS PLACED IN BSS AND SOFTENED AFTER A FEW MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633623 ↗
• MalfunctionFeb 4, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS STUCK ON THE ANTERIOR OPTIC OF THE IOL. SURGEON HAD TO REMOVE HAPTIC FROM THE IOL OPTIC USING TWO UNSPECIFIED INSTRUMENTS. LENS REMAIN STILL IN THE EYE OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21302083 ↗
• MalfunctionDec 31, 2024Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHICH WAS NOT POSSIBLE AS IT WAS NECESSARY TO REMOVE AND USE ANOTHER DEVICE BECAUSE THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LENS WITH AMPUTATED HAPTIC WAS INSIDE THE CAPSULAR SACK. THE AMPUTATED HAPTIC WAS THE PROXIMAL ONE, THE ONE THAT PUSHES THE INJECTOR. DURING IMPLANTATION THERE WAS NO RESISTANCE FROM THE INJECTION MECHANISM. THE SURGERY COMPLETED ON THE SAME DAY, TWO VISCOELASTICS WERE USED TO MANIPULATE THE LENS THAT HAD TO BE REMOVED. THE LENS WAS REMOVED AND AN ADVERSE EVENT REPORT WAS FILLED OUT AT THE SAME TIME. A NEW LENS WAS PLACED SO THAT THE PATIENT COULD LEAVE THE ROOM WITH THE LENS THAT WAS SCHEDULED TO BE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21047805 ↗
• MalfunctionDec 27, 2024Material Discolored; Material Discolored

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMMEDIATELY NOTICED CHANGES ON THE SURFACE. IN ALMOST A WHOLE QUADRANT, THERE WERE IRREGULARITIES/DEPOSITS ON THE ANTERIOR SURFACE, WHICH WERE COLORLESS, MOSTLY IN THE MID-PERIPHERAL AREA IN A CIRCULAR PATTERN, WITH NUMEROUS SATELLITES AROUND IT. THE LENS WAS LEFT IN THE EYE EVEN THOUGH THE MOST CENTRAL CHANGES JUST BARELY TOUCH THE VISUAL AXIS. THE PATIENT WAS VERY SATISFIED, VISION WAS GOOD, AND THE EYE WAS COMPLETELY CALM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21025431 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT HE HAD CATARACT SURGERY ON HIS RIGHT EYE AND THE RESULT WAS VERY GOOD, HE COULD SEE PERFECTLY. HE HAD SURGERY ON HIS LEFT EYE AND DID NOT HAVE THE SAME RESULT, HE REPORTED THAT THE RECUPPERATION TOOK LONGER, AND HE DID NOT SEE VERY WELL BOTH FAR AND NEAR AND NEEDS GLASSES TO COMPENSATE, HE REPORTED THAT HE COMPARED THE VISION OF HIS LEFT EYE WITH A BAD AND OLD TV, WHILE THE RIGHT EYE WITH A NEW FULL HD TV. HE SAID THAT HE HAS A CORNEAL LESION DUE TO THE USE OF CORTICOSTEROIDS AND THAT THE EYE HAS ALREADY BEEN SCRAPED. THE DOCTOR SAID THAT THIS MIGHT BE WHY THE VISION IN HIS LEFT EYE WAS NOT SO GOOD.

  Patient problems: Blurred Vision; Corneal Ulcer

  MAUDE report 20723145 ↗
• InjuryNov 15, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING THE LENS AND DEPLOYING THE HAPTICS, THEY NOTICED THAT ONE HAPTIC WAS LOOSE. SO, THEY PROCEEDED TO REMOVE THE LENS AND REPLACE IT WITH ANOTHER IOL OF THE SAME DIOPTER. LENS WITH AMPUTATED HAPTIC INSIDE THE CAPSULAR BAG. THE AMPUTATED HAPTIC WAS THE PROXIMAL ONE, THAT WAS THE ONE THAT PUSHES THE INJECTOR. DURING THE IMPLANTATION THERE WAS NO RESISTANCE FROM THE INJECTION MECHANISM. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IT WAS CUT INSIDE THE ANTERIOR CHAMBER AND REMOVED IN PIECES. A NEW LENS WITH THE SAME DIOPTER STRENGTH WAS INJECTED AS THE ONE THAT WAS REMOVED. THE INCISION WAS ENLARGED, AND A SUTURE WAS LEFT. THERE WAS CORNEAL EDEMA, WHICH WAS IN THE PROCESS OF DEFLATION. ANATOMICALLY, THE LENS WAS CENTERED IN THE CAPSULAR BAG, THE PUPIL WAS ROUND, AND THE CHAMBER WAS FORMED. THE PATIENT¿S OUTCOME WAS UNCHANGED.

  Patient problems: Corneal Edema

  MAUDE report 20692583 ↗
• MalfunctionJun 18, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19559363 ↗
• MalfunctionJan 16, 2024Scratched Material; Scratched Material

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SURGEON NOTICED A SCRATCHED LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM.ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516621 ↗
• MalfunctionDec 7, 2023Material Discolored; Material Discolored

  A PHYSICIAN REPORTED DE-POLISHING WAS OBSERVED AT THE OPTICS LEVEL OF IOL (INTRAOCULAR LENS) IN 6 MERIDIAN AND WAS APPROXIMATELY 0.2 MM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18281895 ↗
• MalfunctionApr 4, 2023Break; Break

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF BROKEN INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16672323 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH AUTHORITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS IMPLANTED INTO THE CAPSULE AT 10:00 A.M. ON (B)(6) 2022. AFTER PREOPERATIVE EXAMINATION AND CLEANING, THE PATIENT REPORTED TO THE DOCTOR AT 21:00 ON (B)(6) 2022 THAT THE EYE WAS PAINFUL AND UNBEARABLE, AND THE DOCTOR CHECKED THAT IT WAS CORNEAL INJURY. AT 21:10 ON (B)(6) 2022, THE DOCTOR ADMINISTERED PAIN KILLER CAPSULE AND ANTIBIOTIC DROPS.

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

  MAUDE report 16173974 ↗
• MalfunctionAug 24, 2022Failure to Advance; Failure to Advance

  AN OTHER HEALTH PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN CARTRIDGE. THERE WAS PATIENT CONTACT, HOWEVER NO PATIENT IMPACT WAS INVOLVED. THE PROCEDURE WAS COMPLETED WITH BACK UP IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285101 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), EXPERIENCED BLURRED VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT ENDED UP IN HAVING A LASIK PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 15050549 ↗
• MalfunctionJul 12, 2022Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), A STRINGY FOREIGN MATTER WAS OBSERVED. A CREASE/ MARK LEFT AFTER THE FOREIGN MATTER WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14987263 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLARE, STREAKS OF LIGHTS, FLOATERS, AND UNHAPPY WITH HER VISION POST SURGERY AND NIGHT DRIVING VERY HARD AND IS WORSE THEN BEFORE THE SURGERY. THE LENS WAS EXCHANGED WITH ANOTHER LENS IN A SECONDARY PROCEDURE AND PERFORMED PARS PLANA VITRECTOMY. THE PATIENT SYMPTOMS WERE RESOLVED AND PATIENT WAS HAPPY WITH THE RESULT. PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances; Vitreous Floaters

  MAUDE report 14541211 ↗
• MalfunctionMay 27, 2022Defective Device; Defective Device

  A FACILITY REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE, LENS HAD A BUBBLY LINE FROM THE FRONT HAPTIC TO THE CENTER OF THE LENS. DOCTOR IMPLANTED THE LENS AND IT STAYED IN THE PATIENTS EYE. HE STATED IT WOULD NOT AFFECT HIS VISION. ADDITIONAL INFORMATION WAS RECEIVED THAT, THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520673 ↗
• MalfunctionMay 24, 2022Difficult to Advance; Difficult to Advance

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS STUCK IN THE INJECTOR AND THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487303 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS IMPLANTED THEN EXPLANTED. ADDITIONAL INFORMATION WAS PROVIDED STATED THAT PATIENT SUSTAINED A POSTERIOR CAPSULE RUPTURE. THE LENS WAS EXPLANTED SAME DAY FOR DIFFERENT MODEL LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 13585810 ↗
• MalfunctionFeb 14, 2022Crack; Crack

  AN INVENTORY MANAGEMENT SPECIALIST REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, A LENS WAS INSERTED AND REMOVED DUE TO LENS CRACKING. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13521170 ↗
• MalfunctionDec 6, 2021Failure to Eject; Failure to Eject

  A MATERIALS COORDINATOR REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE LENS DID NOT LOAD PROPERLY AND IT DID NOT UNFOLD PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12933128 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CAPSULAR RUPTURE WAS OBSERVED AT 11 O'CLOCK AT THE TIME OF IMPLANTING THE LENS. DUE TO THIS, THE LENS WAS CHANGED FOR ANOTHER 3 PIECE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 12819791 ↗
• MalfunctionSep 29, 2021Crack; Crack

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE CRACKED AFTER THE IMPLANTATION. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND REPORTED THAT AS PER THE SURGEON'S PROGNOSIS THE PATIENT WAS DOING WELL AND NO FURTHER INTERVENTIONS NEEDED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546459 ↗
• InjurySep 22, 2021Adverse 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 EXPERIENCED ENDOPHTHALMITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND REPORTED THAT THE PATIENT HAD AQUEOUS CELL 3+, AQUEOUS FIBRIN AND HYPOPYON AND STROMAL INFILTRATE. THE PATIENT WAS ADMITTED TO HOSPITAL AND WAS TREATED WITH MEDICATIONS. THE PATIENT WAS NON-COMPLIANT WITH APPOINTMENTS AND MEDICATION DUE TO LACK OF ASSISTANCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Infiltrates; Endophthalmitis; Hypopyon; Inflammation

  MAUDE report 12515709 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A RUPTURED SAC AND REQUIRED A VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11913099 ↗