ACRYSOF® SN60WF (REF SN60WF.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380655093160), received between Mar 25, 2021 and Nov 3, 2025 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Crack” (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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Inaccurate Delivery; Failure to Advance; Device Dislodged or Dislocated; Inaccurate Delivery; Failure to Advance; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS LOADED AND THE SURGEON WAS HOLDING IT, THE LENS PREMATURELY CAME OUT OF THE CARTRIDGE BEFORE DELIVERY INTO THE EYE. THE LENS WAS RELOADED, AND WHILE INSERTING INTO THE EYE, THE LENS GOT STUCK IN THE WOUND, SO IT WAS RELOADED AGAIN. THEN THE LENS GOT STUCK IN THE CARTRIDGE. THE SURGEON REQUESTED A NEW LENS, NEW CARTRIDGE, AND NEW INJECTOR. NEW ITEMS WERE GIVEN, THEN CHECKING AND LOADING WERE DONE, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. EVERYTHING WENT WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447308 ↗
• MalfunctionMar 12, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS IRREGULAR. THERE WAS PATIENT CONTACT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581792 ↗
• MalfunctionFeb 21, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED THAT INTRAOCULAR LENS (IOL) DAMAGED WHILE BEING LOADED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434119 ↗
• MalfunctionJan 7, 2025Inaccurate Delivery; Failure to Eject; Inaccurate Delivery; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF WHEN THE SURGEON WAS DOING A WOUND ASSISTED INSERTION OF THE LENS, THE INTRAOCULAR LENS WAS HALF IN AND HALF OUT OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21094372 ↗
• MalfunctionJul 15, 2024Dent in Material; Dent in Material

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE CREASE IN THE CENTER OF THE LENS DURING IMPLANTING. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740245 ↗
• MalfunctionMay 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE IMPLANTED IN THE EYE, A BREAK WAS IDENTIFIED IN THE CENTRAL AREA OF THE OPTIC OF THE LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS THAT HAD THE RUPTURE WAS REMOVED AND ANOTHER SAME MODEL COMPANY LENS WAS IMPLANTED. THE PATIENT HAD POSTOPERATIVE INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 19260302 ↗
• InjuryMay 1, 2024Adverse 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 UNABLE TO DRIVE AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 19220395 ↗
• 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 18463024 ↗
• MalfunctionJan 3, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS CRACKED DURING INJECTION AND HENCE IT COULD NOT BE USED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS CRACKED DURING THE PROGRESSION OF THE LENS IN THE CARTRIDGE. THERE WAS CONTACT WITH PATIENT'S RIGHT EYE, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436043 ↗
• MalfunctionApr 13, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOLDED OVER DURING SURGERY. THE PROCEDURE IS COMPLETED. THERE WAS PATIENT CONTACT NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16735358 ↗
• MalfunctionFeb 10, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THE OPTIC WAS FRACTURED WHEN INJECTING AND FELT VERY STIFF WHEN MOVING IN TO THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT HAD EDEMA, CORNEAL STRIAE. AS PER THE REPORTER MEDICAL OR SURGICAL INTERVENTION IS NOT REQUIRED FOR THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS OF THE SAME POWER AND MODEL WAS IMPLANTED DURING INITIAL PROCEDURE.

  Patient problems: Corneal Edema; Corneal Stromal Edema

  MAUDE report 16352197 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT NEEDED A VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 15884432 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED AN UNEXPECTED OUTCOME. ADDITIONAL INFORMATION RECEIVED AND STATED THAT PATIENT HAD DEBILITATING GLARE AT NIGHT AND WAS UNABLE TO DRIVE. CONSUMER HAD POST OPERATIVE COMPLICATIONS AFTER EXPLANT, YTTRIUM ALUMINUM GARNET (YAG) LASER PERFORMED TO TRY TO ELIMINATE GLARE WITH NO RESOLUTION. PATIENT ENDED UP WITH REMOVAL OF LENS AND POST OPERATIVE CYSTOID MACULAR EDEMA (CME). CME HAS SINCE RESOLVED

  Patient problems: Macular Edema; Visual Disturbances; Visual Impairment

  MAUDE report 15578846 ↗
• MalfunctionSep 13, 2022Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LONG, LINEAR SCRATCH EVIDENT ON THE POSTERIOR FACE OF THE OPTIC RIGHT THROUGH THE VISUAL AXIS. THE SCRATCH WAS CENTRAL IN LOCATION AND ALONG THE LONG AXIS OF THE ROLLED IOL. THE PHOTO IN ¿SURGEON¿S VIEW, IT WAS IN "TEMPORAL INCISION¿, NOTICED THAT SCRATCH IS ORIENTED ~6-12 O¿CLOCK. UPON INJECTION, THE SCRATCH WOULD BE AT 3-9 O¿CLOCK, BUT WHEN IT WAS POSITIONED INTO THE BAG, SURGEON ROTATE IT ABOUT 90 DEGREES CLOCKWISE TO ARRIVE AT THE 6-12 ORIENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410121 ↗
• MalfunctionSep 5, 2022Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAS CRACKED. THE IOL WAS IMPLANTED AND REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15355776 ↗
• InjuryJul 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED ENDOPHTHALMITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT WAS HOSPITALIZED. IT WAS REPORTED THAT PATIENT GOT INFECTION IN THE EYE.

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

  MAUDE report 15114022 ↗
• InjuryApr 18, 2022Adverse 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 DUE TO AN INCREASE OF POSTERIOR PRESSURE, PATIENT WAS LEFT APHAKIC AND WAS UNABLE TO CONTINUE WITH ORIGINALLY PLANNED SURGERY. A REPLACEMENT WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 14135868 ↗
• InjuryFeb 23, 2022Crack; Crack

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A CRACK WAS OBSERVED IN THE LENS AFTER INSERTING IT. THE LENS REMAINED IMPLANTED AS THE PHYSICIAN THOUGHT IT MAY BE JUST AFFECTING THE PERIPHERY. THE VISION DID NOT IMPROVE HENCE THE SURGEON DECIDED TO EXPLANT THE LENS IN A SECONDARY PROCEDURE. THE LENS WAS REPLACED WITH A DIFFERENT LENS OF THE SAME POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13583416 ↗
• MalfunctionJan 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT FOLLOWING INSERTION OF THE INTRAOCULAR LENS (IOL), THE PARTICULATE MATTER WAS DISCOVERED ON THE LENS AFTER INSERTION. THE SURGEON REMOVED THE LENS AND REPLACED WITH A NEW LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151604 ↗
• InjuryDec 24, 2021Defective Device; Defective Device

  A MATERIALS MANAGER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT WAS UNABLE TO SEE CLEARLY AND MECHANICAL MALFUNCTION. THE LENS WAS EXCHANGED FOR ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 13084406 ↗
• MalfunctionSep 1, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A MATERIALS MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD PROPERLY WHEN ATTEMPTED TO INSERT INTO A PATIENT'S EYE. THE PROCEDURE WAS COMPLETED THE SAME DAY WITH ANOTHER LENS, SAME TYPE, AND DIOPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406840 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED FOREIGN BODY SENSATION (FBS) AND WAS RUBBING EYE EXCESSIVELY. CAUSED A CORNEAL ABRASION AND HEALED AFTER FEW WEEKS. BLURRY VISION, BLOOD SHOOT EYE AND DRY EYE. THE PATIENT WAS PRESCRIBED WITH RESTASIS. HIS BCVA IMPROVED FROM 20/400 BEFORE SURGERY TO 20/40 AFTER SURGERY. THE SURGEON HAS DIAGNOSED DRY EYE WITH TREATMENT. PCP TO INVESTIGATE POSSIBLE ALLERGIC REACTION. ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Corneal Abrasion; Dry Eye(s); Foreign Body Sensation in Eye; Red Eye(s)

  MAUDE report 12335305 ↗
• MalfunctionJun 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT THE LENS PRESENTED A "BURR" IN THE CENTRAL PART THAT OCCURRED WHEN THE LENS WAS ALREADY IMPLANTED, IT WAS TRIED TO BE REMOVED WITH FORCEPS BUT COULD NOT GET REMOVED. THE PENDING VISUAL RESULT OF THE PATIENT WILL REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053216 ↗
• MalfunctionJun 14, 2021Inaccurate Delivery; Inaccurate Delivery

  A CUSTOMER REPORTED THAT THE INTRAOCULAR LENS IMPLANTED AND REMOVED, LENS GOT STUCK IN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11991139 ↗
• MalfunctionMar 26, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN INTRAOCULAR LENS (IOL) REPLY CARD WAS RECEIVED INDICATING A DAMAGED LENS. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11574642 ↗