ACRYSOF® SN60WF (REF SN60WF.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380655093207), received between Apr 13, 2021 and Aug 13, 2026 — classified as 12 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (6 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A report was received from the health authority and reported following an intraocular lens (IOL) implant procedure, the patient experienced hypersensitive to light both indoor lighting and especially sunlight. The patient experienced these after her cataract surgery in 2022. When the patient was outdoors, she wears sunglasses fitted by an optician with wide temples and they do not help. In (b)(6) 2026, she visited an optician and according to the doctor there was nothing wrong with her eyes. After spending time outdoors, her eyes became extremely strained and afterward she had difficulty focusing on vision. The areas around her eyes become red and swollen and her eyes look tired and overworked. She becomes very fatigued and develops headaches, she cannot stay outdoors on a sunny day and becomes extremely tired. Patient feels that her life was limited by light sensitive eyes. Before the cataract surgery, she did not have these problems. Additional information was received and stated, patient was informed that the light sensitivity would improve after 6 weeks of surgery. However, she had experienced light sensitivity ever since and it was difficult to be outdoors in sunlight and dazz

  Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances

  MAUDE report 50234569 ↗
• MalfunctionMay 7, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT PHACOEMULSIFICATION AND CATARACT EXTRACTION OF THE LEFT EYE WITH PRIMARY INTRAOCULAR LENS (IOL) IMPLANTATION. DURING THE SURGERY, THE NURSE LOADED THE IOL INTO THE INJECTOR AND THE PHYSICIAN ADVANCED THE LENS INTO THE CAPSULAR BAG. AT THAT TIME, A CRACK WAS OBSERVED ON THE SURFACE OF THE IMPLANTED LENS. THE LENS WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW UNSPECIFIED LENS OF THE SAME POWER. THE REMAINING SURGICAL PROCEDURES WERE SUCCESSFULLY COMPLETED ON THE SAME DAY, AND THE PATIENT WAS SAFELY TRANSFERRED BACK TO THE WARD. IT WAS REPORTED THAT IT MAY HAVE BEEN A QUALITY ISSUE WITH THE LENS, OR IT COULD HAVE BEEN DUE TO IMPROPER OPERATION OR IMPROPER FORCE DURING IMPLANTATION, WHICH CAUSED THE FRACTURE DURING INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 25113491 ↗
• MalfunctionApr 7, 2026Failure to Deliver; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS INJECTED, IT STRUCK BETWEEN THE BEZEL AND THE CARTRIDGE, AFTER REMOVAL IT BROKE THE HAPTIC. HENCE A SECOND LENS WAS USED IT WAS DAMAGED AND BOTH THE LENS WERE NOT IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24796340 ↗
• MalfunctionApr 7, 2026Failure to Deliver; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS INJECTED, IT STRUCK BETWEEN THE BEZEL AND THE CARTRIDGE, AFTER REMOVAL IT BROKE THE HAPTIC. HENCE A SECOND LENS WAS USED IT WAS DAMAGED AND BOTH THE LENS WERE NOT IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24796339 ↗
• MalfunctionApr 2, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING UNKNOWN TIME OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24766977 ↗
• MalfunctionMar 18, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON OPENING THE LENS, IT WAS FOUND THAT ONE OF THE HAPTICS WAS BROKEN REMOVED IT FROM THE INJECTOR, RETURNED IT TO ITS PACKAGING. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM, THE SURGERY WAS FINISHED WITH ANOTHER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630134 ↗
• MalfunctionMar 16, 2026Failure to Unfold or Unwrap; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF LENS IT WAS NOTED THAT BOTH THE LENS HAPTICS WERE TIGHTLY ADHERED TO THE OPTIC AND COULD ONLY BE SEPARATED WITH DIFFICULT MANUAL MANIPULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT¿S CURRENT CONDITION WAS GOOD; NO TREATMENT WAS APPLIED. A SLIGHT SCRATCH OCCURRED ON THE LENS, BUT NOT ON THE OPTICAL AXIS. ONLY THE EYE THAT WAS OPERATED ON WAS AFFECTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 3 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605632 ↗
• MalfunctionMar 16, 2026Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS WERE TIGHTLY ADHERED TO THE OPTIC AND COULD ONLY BE SEPARATED WITH DIFFICULT MANUAL MANIPULATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT A SLIGHT SCRATCH OCCURRED ON THE INTRAOCULAR LENS; HOWEVER, THE SCRATCH WAS LOCATED AWAY FROM THE OPTICAL AXIS. THE PATIENT¿S CURRENT CONDITION IS REPORTED TO BE GOOD.

  Patient problems: Insufficient Information

  MAUDE report 24603273 ↗
• MalfunctionFeb 19, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  A PURCHASING DIRECTOR REPORTED AN ISSUE THAT OCCURRED DURING LOADING OF THE INTRAOCULAR LENS (IOL). THERE WAS DIFFICULTY LOADING THE LENS INTO THE CARTRIDGE, AND THE HAPTICS WERE MISPLACED. THEREFORE, THE LENS WAS NOT IMPLANTED. THE SURGERY WAS COMPLETED ON SAME DAY. PATIENT CONTACT DID NOT OCCUR WITH THE DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387086 ↗
• InjuryDec 23, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON NOTICED SCRATCH OR STRAIN ON OPTICAL ZONE. THE LENS WAS IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT PRESCRIBED WITH HYDROCORTISONE 250 MG INTRAVENOUSLY AND TOPICAL MOXIFLOXACIN EVERY 3 HOURS DUE TO POSSIBLE INFLAMMATION AT RISK OF UVEITIS DUE TO EXCESSIVE MANIPULATION FROM DOUBLE IMPLANTATION AND EXPLANTATION OF AN IOL.

  Patient problems: Insufficient Information

  MAUDE report 23876902 ↗
• InjuryDec 23, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON NOTICED SCRATCH OR STRAIN ON OPTICAL ZONE. THE LENS WAS IMPLANTED AND REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH NEW LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT PRESCRIBED WITH HYDROCORTISONE 250 MG INTRAVENOUSLY AND TOPICAL MOXIFLOXACIN EVERY 3 HOURS DUE TO POSSIBLE INFLAMMATION AT RISK OF UVEITIS DUE TO EXCESSIVE MANIPULATION FROM DOUBLE IMPLANTATION AND EXPLANTATION OF AN IOL.

  Patient problems: Insufficient Information

  MAUDE report 23876718 ↗
• MalfunctionNov 4, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LOADING THE IOL HAPTIC HAS BEEN CUT DURING THE INSERTION IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465234 ↗
• MalfunctionJul 9, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED AND IT WAS DISCARDED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 22459437 ↗
• MalfunctionJul 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN IT WAS ALREADY PREPARED TO BE INJECTED, THE SURGEON NOTICED THAT THE IOL WAS BROKEN SO HE DECIDED TO REMOVE IT AND HE HAS TO OPEN ANOTHER LENS TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22437475 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DEFORMED/ASYMMETRIC. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE EVENT OCCURRED DURING LOADING AND THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719406 ↗
• MalfunctionMar 25, 2025Break; Failure to Deliver; Break; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE, THE LENS STUCK IN THE DELIVERY SYSTEM, DUE TO THE DAMAGE IN THE LENS, THE LENS WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687506 ↗
• MalfunctionJan 3, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL HAD REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, LENS HAPTIC STUCK TO OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21065898 ↗
• MalfunctionDec 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT HAD A DIAGNOSIS OF GLAUCOMA, VERY MILD PCO (POSTERIOR CAPSULAR OPACIFICATION) FOR WHICH LASER WILL NOT HELP THE VISION AND GLISTENING WAS DISCUSSED WITH THE PATIENT. THE PATIENT ALSO HAD NEGATIVE DYSPHOTOPSIA IN BOTH EYES (OU), SO NO TREATMENT IS REQUIRED FOR IT.

  Patient problems: Blurred Vision; Glaucoma; Visual Disturbances; Visual Impairment

  MAUDE report 20890668 ↗
• MalfunctionNov 27, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS DAMAGED BY HANDPIECE INJECTOR. AFTER IMPLANTING IOL INTO PATIENT¿S EYE THE SURGEON NOTICED IOL DAMAGED AND REMOVE IT FROM PATIENT¿S EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT SURGERY WAS COMPLETED WITH SPARE IOL ON THE SAME DAY. DUE TO THIS MORE SURGERY TIME WAS TAKEN, PATIENT HAD INFECTION AND ALREADY ON MEDICATION.

  Patient problems: Insufficient Information

  MAUDE report 20793879 ↗
• MalfunctionNov 12, 2024Failure to Eject; Failure to Eject

  A THEATRE TEAM LEADER REPORTED THAT BEFORE SURGERY, THE LENS CAME OUT INVERTED AND WAS NOT IMPLANTED. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED ON 15-OCT-2024, IT WAS REPORTED THAT THE LENS CAME OUT OF THE CARTRIDGE CONVEX. THE DOCTOR WANTED TO CHANGE THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 20665035 ↗
• InjuryNov 8, 2024Adverse 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 EXPERIENCED BLURRY VISION. CLINICAL REASON BEING MENTIONED AS HYPEROPIC REFRACTIVE OUTCOME. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT. THE IOL WAS EXPLANTED AND EXCHANGED WITH ANOTHER COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 20642102 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS. IN THE FIRST FOLLOW UP THE PATIENT HAD NO SYMPTOMS. IN THE SECOND FOLLOW UP PATIENT DEVELOPED MINOR ENDOPHTHALMITIS, WHICH WAS TREATED IMMEDIATELY AND SUCCESSFULLY. PATIENT IS FINE NOW AND IS UNDER OBSERVATION. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 5. ADDITIONAL INFORMATION WAS RECEIVED AND MENTIONED THAT PATIENT WAS TREATED WITH INTRAVITREAL INJECTION OF ANTIBIOTICS.

  Patient problems: Endophthalmitis

  MAUDE report 19124570 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING PATIENT ISSUES WERE RESOLVED AND VISION WAS SAME PRE OP AND POST OP.

  Patient problems: Endophthalmitis

  MAUDE report 19115776 ↗
• MalfunctionOct 20, 2023Failure to Eject; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS ONLY PARTIALLY CAME OUT OF THE CARTRIDGE, AND APPLYING PRESSURE TO THE INJECTOR PLUNGER DID NOT YIELD THE DESIRED RESULTS. HENCE THE LENS AND CARTRIDGE WAS REPLACED WITH SIMILAR ONE, AND THE IMPLANTATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17973301 ↗
• MalfunctionJun 6, 2023Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OPAQUE IOL NOTED AFTER 10 YEARS OF IMPLANTATION IN EYE.

  Patient problems: Insufficient Information

  MAUDE report 17069783 ↗