ACRYSOF® SN60WF (REF SN60WF.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00380655093276), received between May 5, 2021 and Sep 25, 2026 — classified as 11 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Deliver

  A health care professional reported that during an intraocular lens (IOL) implant procedure, lens appeared hard/stiff and was very difficult to advance through the cartridge. They attempted to use both BSS (Balanced salt solution) and company viscoelastic; however, the lens remained stiff and the lens did not deploy.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50898919 ↗
• MalfunctionJan 21, 2026Break

  A SURGEON PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING THE IOL AT THE TIME OF INSERTION, THE SURGEON NOTICED THAT THE IOL HAPTIC WAS CUT. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH A REPLACEMENT OF THE IOL ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129243 ↗
• MalfunctionDec 3, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHILE INJECTING THE LENS, PLUNGER CAUGHT THE HAPTIC AND BROKEN AS SURGEON WAS ROTATING THE LENS, THE OTHER HAPTIC FELL OFF. THERE WAS NO REAL HARM, BUT THE SURGERY WAS COMPLETED BY EXTENDING THE OPERATING TIME AS THE BROKEN LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704292 ↗
• MalfunctionOct 31, 2025Material Discolored; Material Discolored

  THE HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, LENS LOOKED DIRTY UNDER MICROSCOPE AFTER IMPLANTATION. HENCE THE SURGEON EXPLANTED THE LENS AND REPLACED IT WITH BACK UP LENS DURING THE SAME PROCEDURE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437812 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN VIA STUDY REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD A MILD HYPEROPIC RESIDUAL REFRACTION SINCE VISITS 2 (B)(6) 2024, AND VISIT 2A (B)(6) 2024, AT THAT MOMENT PATIENT VISION QUALITY WAS DEEMED AS GOOD AND IT WAS NOT CONSIDERED AS AN ADVERSE EVENT SINCE NO SYMPTOMS WHERE PRESENT. ON VISIT 5A (B)(6) 2025, PATIENT HAD A VISUAL ACUITY OF LESS THAN 20/20, SO THEY MADE AN UNSCHEDULED APPOINTMENT TO EVALUATE IF PATIENT WAS ELIGIBLE FOR LASIK WHICH WAS PERFORMED ON (B)(6) 2025, AFTER THE APPOINTMENT PATIENT WAS DEEMED AS A GOOD CANDIDATE FOR LASIK SURGERY SINCE VISUAL ACUITY WAS CAUSED BY MILD HYPEROPIA BUT AFTER THE APPOINTMENT PATIENT TOLD THAT HAD TO THINK ABOUT HAVING ANOTHER SURGERY BEFORE ACCEPTING THE PROCEDURE, THE PROCEDURE WAS PERFORMED ON (B)(6) 2025, AFTER THAT AN UNSCHEDULED VISIT WAS PERFORMED ON (B)(6) 2025 WHERE WE FOUND A GOOD REFRACTIVE RESULT AND THE EVENT WAS DEEMED AS A RESOLVED EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23069781 ↗
• MalfunctionSep 9, 2025Break; Break

  AN ADMINISTRATOR/SUPERVISOR REPORTED WITH A DESCRIPTION OF LENS FOR BROKEN LEGS, CANNOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23002845 ↗
• MalfunctionMay 20, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE LOADING INTO CARTRIDGE LENS WAS FLOATING UP MAKING IT STUCK WHEN LOADING INTO PATIENT'S EYE. LENS COULD NOT BE LOAD AND LIKELY TO HAVE SCRATCH MARK ON LENS FROM TIP OF INJECTOR. SO, THE SURGEON DID NOT USE THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING THE BACKUP LENS.

  Patient problems: Insufficient Information

  MAUDE report 22051792 ↗
• MalfunctionApr 23, 2025Break; Break

  BATCH CASE RECEIVED FROM HA PORTAL, REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS FOUND TO BE BROKEN WHEN PREPARING TO LOAD INTO THE CHAMBER. THE SAME SPECIFICATION AND MODEL OF IOL WAS IMMEDIATELY REPLACED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21888566 ↗
• MalfunctionMar 19, 2025Break; Break

  A PHARMACIST REPORTED THAT HAPTIC THAT BROKE IN THE INJECTOR. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642456 ↗
• MalfunctionMar 17, 2025Failure to Deliver; Failure to Deliver

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY THE LENS FAILED DURING THE LOADING PROCESS SO IT WAS NOT IMPLANTED AND THE SURGEON REQUESTED IT TO BE DISCARDED AND THE SURGERY WAS COMPLETED BY USING REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21617631 ↗
• MalfunctionMar 10, 2025Failure to Unfold or Unwrap; Material Split, Cut or Torn; Failure to Unfold or Unwrap; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED IN THE COMPANY CARTRIDGE WITH COMPANY INJECTOR USING AMVISC PLUS. WHEN IMPLANTING THE TRAILING HAPTIC WAS STUCK ON THE ANTERIOR SURFACE AND WAS RELEASED IN 30 SECONDS USING A SECOND INSTRUMENT. DOCTOR THEN NOTICE CRACK IN THE OPTIC. DOCTOR THOUGHT THE LENS MAY HAVE BEEN SITTING IN THE CARTRIDGE AT AN ANGLE WHEN LOADED WHICH CAUSED ADDITIONAL PRESSURE ON THE LENS. WHEN IMPLANTING THE INJECTOR FELT SMOOTH NO RESISTANCE LENS WAS EXPLANTED AND NEW LENS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21561694 ↗
• MalfunctionFeb 6, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS LOADED INTO COMPANY INJECTOR, WITH COMPANY CARTRIDGE AND NON-COMPANY VISCOELASTIC. ON IMPLANTATION THE SURGEON NOTICED ONE OF THE HAPTICS WAS DAMAGED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21321669 ↗
• MalfunctionJan 3, 2025Break; Break

  A PHYSICIAN REPORTED DURING LOADING THE LENS INTO THE CARTRIDGE, ONE OF THE HAPTIC BROKEN AND PROCEDURE COMPLETED USING ANOTHER LENS ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT LEADING HAPTIC BROKEN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064829 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS UNDER TREATMENT FOR 15 DAYS FOR POST OP INFLAMMATION AND RISE IN IOP. AS PER SURGEON IT WOULD HAVE IMPACTED PATIENT EYE SIGHT, IF IT WAS NOT ADDRESSED ON TIME.

  Patient problems: Inflammation; Intraocular Pressure Increased

  MAUDE report 18462946 ↗
• MalfunctionJun 29, 2023Failure to Eject; Failure to Eject

  A NURSE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) WHICH IS NOT IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE IOL INJECTED IN EYE INCORRECTLY. THE IOL WAS EXCHANGED FOR ANOTHER LENS DURING INITIAL IMPLANT PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17225307 ↗
• MalfunctionJun 26, 2023Failure to Advance; Failure to Advance

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THERE WAS OBSTRUCTION OF THE CARTRIDGE WITH ITS RUPTURE AND BLOCKAGE OF THE PASSAGE OF THE IOL. THERE WAS PATIENT CONTACT NOTED. THE PROCEDURE WAS COMPLETED BY REPLACING IOL AND CARTRIDGE OF SAME BRAND. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199125 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FELT SOMETHING LIKE A TEARING IN THE CORNER OF THE EYE IN BOTH EYES AND DISCOMFORT AS IF SOMETHING HAD ENTERED, PATIENT HAD ALSO LOST FAR VISION, NOT EVEN TO WATCH TV. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Discomfort; Foreign Body Sensation in Eye

  MAUDE report 17077044 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FELT SOMETHING LIKE A TEARING IN THE CORNER OF THE EYE - IN BOTH EYES - AND DISCOMFORT AS IF SOMETHING HAD ENTERED, PATIENT HAD ALSO LOST FAR VISION, NOT EVEN TO WATCH TV. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Discomfort; Foreign Body Sensation in Eye

  MAUDE report 17077043 ↗
• MalfunctionJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REFRACTIVE SURPRISE. THE LENS EXCHANGE IS BEING CONSIDERED FOR THIS PATIENT HOWEVER A DECISION ON THIS WON¿T BE MADE UNTIL FURTHER INVESTIGATION IS DONE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, UPON FURTHER INVESTIGATION OF THE PATIENT LENS HAS NOT BEEN EXPLANTED AND A DECISION ON WHETHER A LENS EXCHANGE WILL GO AHEAD WILL ONLY BE MADE AFTER OTHER INTERVENTION. THERE IS CURRENTLY NO COMPLAINT WITH THE LENS EXCEPT THE REFRACTIVE SURPRISE WHICH THE SURGEON THINKS IS DUE TO THE POSITION IN THE EYE.

  Patient problems: Visual Impairment

  MAUDE report 16183212 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT SUFFERED FROM SEVERAL INTOLERANCES. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, SINCE LENS WAS IMPLANTED THE PATIENT HAD STINGING IN LEFT EYE, DAILY SEVERE HEADACHES, FINGERNAILS CRACKED, HEAD OVERHEATED, OPTIC NERVE IRRITATION, SAND GRAIN SENSATION WHICH LED HOSPITALIZATION. CONTINUATION OF SICCA THERAPY RECOMMENDED ADDITIONAL INFORMATION HAS BEEN REQUEST.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache; Visual Disturbances

  MAUDE report 15751580 ↗
• MalfunctionJul 5, 2022Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE LENS WAS FOUND TO BE BENT. THE IOL WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14914108 ↗
• InjuryJun 27, 2022Difficult to Advance; Scratched Material; Difficult to Advance; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE IOL NOTED TO BE SCRATCHED AFTER INSERTION. ADDITIONAL INFORMATION WAS RECEIVED THAT, AS PER SURGEON¿S OPINION THE IOL MAY HAVE NOT SEATED WHEN PUSHING FORWARD/LOADING. THE PATIENT HAD CORNEAL EDEMA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. PATIENT WAS NOT HOSPITALIZED DUE TO THE EVENT. PATIENT'S ISSUES GOT RESOLVED. VISUAL PROGNOSIS WAS GOOD.

  Patient problems: Corneal Edema

  MAUDE report 14831772 ↗
• 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, THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520655 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. THE YAG (YTTRIUM ALUMINUM GARNET) WAS PERFORMED POST OPERATION. THE SURGEON DOES NOT SEE ANY REASON FOR GLARE OR HALOS. THE SURGEON HAS PERFORMED GLARE TESTING AND DID NOT FIND ANY GLARE. SLIT LAMP EXAM SHOWS LENS IN GOOD POSITION WITH NO SIGNS OF GLISTENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH ONE OF THE TWO EYES.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13480802 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. THE YAG (YTTRIUM ALUMINUM GARNET) WAS PERFORMED POST OPERATION. THE SURGEON DOES NOT SEE ANY REASON FOR GLARE OR HALOS. THE SURGEON HAS PERFORMED GLARE TESTING AND DID NOT FIND ANY GLARE. SLIT LAMP EXAM SHOWS LENS IN GOOD POSITION WITH NO SIGNS OF GLISTENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH ONE OF THE TWO EYES.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13480798 ↗