ACRYSOF® SN60WF (REF SN60WF.245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380655093283), received between Mar 25, 2021 and Mar 30, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Device Damaged Prior to Use; Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UNDER A MICROSCOPE, THE SURGICAL TECHNICIAN NOTICES A SLIGHT CRACK IN THE INTRAOCULAR LENS, INFORMED THE DOCTOR AND THEY DECIDE TO REPLACE IT, REMOVING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24722153 ↗
• MalfunctionNov 19, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) AFTER IMPLANTATION A MARK WAS OBSERVED ON THE CENTRAL OPTIC ZONE OF THE IOL. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND BACKUP LENS WAS INSERTED WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23597745 ↗
• 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 LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23069785 ↗
• MalfunctionMar 25, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT . THE SURGERY COMPLETED WITH REPLACEMENT LENS DURING SAME PROCEDURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691499 ↗
• MalfunctionOct 30, 2024Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS STUCK IN THE CARTRIDGE DURING DELIVERY OF THE IOL. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570805 ↗
• MalfunctionNov 29, 2023Defective Component; Scratched Material; Defective Component; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC DEFECTIVE AND SCRATCHED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18226971 ↗
• MalfunctionAug 22, 2023Break; Break

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT, THE INTRAOCULAR LENS (IOL) HAD A DEFECT, IT BROKE INTO TWO PIECES DURING IMPLANTATION, UPON REMOVAL FROM THE CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. THE DAMAGED LENS WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EYE WAS CALM, THE CORNEA WAS TRANSPARENT, THE ANTERIOR CHAMBER WAS OF MODERATE DEPTH, THE INTRAOCULAR LENS (IOL) WAS IN THE CAPSULAR BAG AND WELL-CENTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594560 ↗
• MalfunctionFeb 24, 2023Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A LENS DEFORMED AFTER INSERTION IN TO THE EYE. THE LENS WAS REMOVED AND COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434636 ↗
• MalfunctionFeb 6, 2023Break; Material Deformation; Break; Material Deformation

  A PHYSICIAN REPORTED THAT DURING SURGERY, WHEN THE LENS WAS IMPLANTED IN THE EYE, THE TIP OF THE INJECTOR DEFORMED THE LENS AND THE HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED BY REPLACING WITH THE SAME MODEL LENS.

  Patient problems: Insufficient Information

  MAUDE report 16303146 ↗
• MalfunctionJan 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A FOREIGN BODY IN LENS REPORTED THAT THERE WAS A FOREIGN BODY IN LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16085442 ↗
• MalfunctionJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS UNFOLDED WITH A CENTRAL SCRATCH. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16084769 ↗
• InjuryJul 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMIC ASSISTANT REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) THE PATIENT HAD BLURRY AND CLOUDY VISION. GLARE WHILE DRIVING AT NIGHT AND HAS A GLARE WHEN SHE PLAYS TENNIS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. LIMBAL RELAXATION INCISIONS WAS PERFORMED. THE PATIENT ISSUES WERE RESOLVED AND THE DOCTOR¿S PROGNOSIS WAS EXCELLENT. THERE WAS NO PATIENT HARM INVOLVED. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14897509 ↗
• MalfunctionJun 17, 2022Scratched Material; Scratched Material

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A CREASE/ LINE ON LENS, WAS NOTED AFTER INSERTION. THE LENS WAS NOT REMOVED FROM THE EYE DUE TO THE POTENTIAL RISKS/ COMPLICATIONS OF DOING AND BECAUSE IT WAS NOT IN THE PATIENT¿S FIELD OF VISION. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14729380 ↗
• MalfunctionJun 13, 2022Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK WAS FOUND ON IOL OPTIC AFTER IMPLANTED IN THE PATIENT'S EYE, THEN REMOVED. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14674208 ↗
• MalfunctionApr 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION WHICH WAS IMPLANTED IN 2014, THE PATIENT HAD EXPERIENCED BLURRY VISION AND GLISTENINGS AFTER FOUR YEARS FROM THE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT IS WAITING FOR AN EXPLANT. NO MEDICATION HAS BEEN USED TO TREAT THE EVENT OF GLISTENINGS. ARTIFICIAL TEARS WERE USED BUT NO SPECIFIC INDICATION WAS MENTIONED, THE PATIENT DID NOT HAVE DRY EYES. EYE INSPECTION REVEALED NO OTHER PATHOLOGY OTHER THAN LENS GLISTENING. PATIENT HAD VA OF 20/20 BUT NOT CLEAR VISION. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT ISSUES HAVE RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 14207761 ↗
• MalfunctionMar 17, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AN OPHTHALMIC SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A WHITE SUBSTANCE WAS OBSERVED AND VERY HARD TO REMOVE THE SUBSTANCE FROM BACK OF THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13800928 ↗
• MalfunctionFeb 28, 2022Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE OPERATING TEAM HAD TO USE A BACKUP LENS SINCE THE REGULAR LENS WAS FOUND OUT TO BE DEFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13618122 ↗
• MalfunctionFeb 12, 2022Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS WASTED AND WAS EXTRACTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13519088 ↗
• MalfunctionJul 1, 2021Difficult to Fold, Unfold or Collapse; Failure to Advance; Difficult to Fold, Unfold or Collapse; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, LENS WAS HARD TO FOLD INTO CARTRIDGE. THE LENS STRUGGLED TO ADVANCE FORWARD WITH INTRODUCER AND GOT STUCK AT THE END OF THE CARTRIDGE IN THE PATIENT'S EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099496 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). HYPOPYON WAS PRESENT DURING THE POSTOPERATIVE VISIT. THE PATIENT WAS TREATED WITH A COMBINED ANTIBIOTIC-CORTICOSTEROID OPHTHALMIC MEDICATION EVERY HOUR. THE PATIENT'S SYMPTOMS HAVE RESOLVED. THIS REPORT IS FOR PATIENT 3 (INTRAOCULAR LENS).

  Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11838356 ↗
• MalfunctionMar 25, 2021Scratched Material; Scratched Material

  A CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND A MARK WAS NOTICED ON THE OPTICAL PLATE. THE LENS WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE WITH NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569004 ↗