ACRYSOF® SN60WF (REF SN60WF.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380655093153), received between Mar 3, 2021 and Sep 18, 2026 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, a posteriorly dislocated lens was observed, with an open fundus in the affected eye, and surgical repair of the eye was planned. Surgery was recommended. Under local anesthesia, the eye was prepared and draped following periocular cleaning. The eyelids were opened using an eye speculum, and side-port openings were created with an MVR (Micro Vitreoretinal Blade) instrument. A 2.8 mm main incision was made, through which the dislocated lens was removed. An anterior vitrectomy was then performed, and a three-piece intraocular lens was implanted in the sulcus. The main incision was secured with a single suture. Following a subconjunctival antibiotic injection, a leak test was performed, and the procedure was completed successfully. The diagnosis included blepharoconjunctivitis and post-surgical cataract.Additional information was requested and received, stating that the lens was removed from the patient's eye, discarded during the surgery, and thrown away. The patient's condition was very poor. The surgeon informed the patient that nothing more could be done for that eye and that the

  Patient problems: Conjunctivitis; Posterior Capsule Opacification

  MAUDE report 50814632 ↗
• MalfunctionSep 19, 2025Particulates; Material Twisted/Bent; Scratched Material; Particulates; Material Twisted/Bent; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, ASYMMETRICAL HAPTICS, OPTIC MARKINGS, AND LENS FLUFF WERE OBSERVED.ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23094397 ↗
• MalfunctionSep 16, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKE OFF WHEN TRYING TO LOAD INTO CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23061866 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21970726 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED WITH A DESCRIPTION OF LENS WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21676641 ↗
• MalfunctionMar 4, 2025Inaccurate Delivery; Device Dislodged or Dislocated; Inaccurate Delivery; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS LOADED, UPON INJECTING INTO EYE, NOT FULLY INJECTED AND STUCK IN WOUND. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 21512880 ↗
• MalfunctionFeb 25, 2025Product Quality Problem; Failure to Deliver; Material Split, Cut or Torn; Product Quality Problem; Failure to Deliver; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FELT DIFFERENT AND STIFFER. LENS COULD NOT BE ADVANCED INTO THE CARTRIDGE BUT TURNED OUT AND CAUSING THE OPTICS TO BE TORN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE OPERATION WAS COMPLETED BY USING THE BACKUP IOL.

  Patient problems: Insufficient Information

  MAUDE report 21456508 ↗
• MalfunctionMay 14, 2024Material Split, Cut or Torn; Failure to Eject; Material Split, Cut or Torn; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INTRODUCING THE IOL INTO THE EYE AND INJECTING IT, IT GETS STUCK IN THE INJECTOR, TEARING AND DAMAGING THE OPTIC. LENS WAS EXPLANTED AT INITIAL PROCEDURE. REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19308097 ↗
• MalfunctionJan 4, 2024Failure to Unfold or Unwrap; Scratched Material; Failure to Unfold or Unwrap; Scratched Material

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON MENTIONED THAT AFTER PLACING THE IOL IN THE BAG, ONE OF THE HAPTICS STUCK TO THE OPTIC. WHEN PUSHED IT CAME LOOSE, BUT THE IMPRINT WAS REMAINED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO HEALTH CONSEQUENCES TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443248 ↗
• MalfunctionDec 6, 2023Material Split, Cut or Torn; Failure to Eject; Material Split, Cut or Torn; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INTRODUCING THE IOL INTO THE EYE AND INJECTING IT, IT GETS STUCK IN THE INJECTOR, TEARING AND DAMAGING THE OPTIC. LENS WAS EXPLANTED AT INITIAL PROCEDURE. REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18273952 ↗
• MalfunctionDec 6, 2023Failure to Unfold or Unwrap; Scratched Material; Failure to Unfold or Unwrap; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO HEALTH CONSEQUENCES TO PATIENT.

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

  MAUDE report 18273038 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENTS VISION WAS NOT CLEAR AND NOTES HAZY VISION LIKE A RAINY DAY. YAG LASER WAS PERFORMED HOWEVER WITH NO HELP. CONSUMER STATED THAT SHE WOKE UP IN THE MIDDLE OF PROCEDURE WITH PAIN. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17478836 ↗
• MalfunctionDec 21, 2022Failure to Advance; Failure to Advance

  A SUPERVISOR REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT INJECT PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 16023269 ↗
• InjuryAug 5, 2022Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 5-7 YEARS AGO DEVELOPED BLURRY VISION, AND WAS NOTED TO HAVE A MYOPIC SHIFT IN HER LEFT EYE THAT HAS NOW STABILIZED. SHE HAD WORSENING GLARE AS WELL. HER VISION DECREASED TO ABOUT 20/30 EVEN WITH THE NEW REFRACTION. ON EXAM IT LOOKS LIKE SHE HAS A THICKENED AND SOMEWHAT OPACIFIED OPTIC. THERE WAS NO TRAUMA OR OTHER UNUSUAL FINDING ON EXAM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15175361 ↗
• MalfunctionApr 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE DURING THE DAY AND THE NIGHT VISION WAS VERY POOR. IT WAS VERY HARD TO SEE UNDER DIM LIGHTS AND WAS CONSIDERING A LENS EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL FOLLOW UP WAS NOT REQUIRED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14083153 ↗
• InjuryJan 27, 2022Material Opacification; Material Opacification

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CORNEAL CONDITION HAS CHANGED AND IOL OPACIFICATION OCCURRED. THE IOL EXCHANGE IS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 13363928 ↗
• MalfunctionOct 26, 2021Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT, THERE WAS A CRACK IN LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696559 ↗
• MalfunctionSep 14, 2021Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN IOL IMPLANT PROCEDURE THE SURGEON NOTICED AN AIR BUBBLE INSIDE THE LENS AND DECIDED TO EXPLANT IT. A NEW IOL WAS IMPLANTED WITH NO ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 12468835 ↗
• MalfunctionSep 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PIECE OF CELLOPHANE LABEL WAS TUCKED IN THE LOADED LENS. THE PIECE OF LABEL WAS INJECTED IN THE EYE ALONG WITH THE IOL. THE LABEL WAS REMOVED FROM THE EYE. THERE WAS NO PATIENT HARM REPORTED. THE PHYSICIAN COULD NOT LOCATE A DEFECT IN THE ORIGINAL LABEL THAT MATCHED THE PIECE THAT WAS REMOVED FROM THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423681 ↗
• MalfunctionMay 10, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE A LENS HAD A MARK ON IT; DAMAGE NOTICED ON INTERIOR SIDE OF LENS. THERE WAS CONTACT WITH THE PATIENT, AND THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT DAMAGE WAS NOTED ON THE ANTERIOR SURFACE OF THE LENS DUE TO THE INJECTOR. AT THIS POINT, IT WAS DETERMINED THAT THE SURFACE DAMAGE WOULD BE VISUALLY SIGNIFICANT AND INTRAOCULAR LENS REMOVAL WAS NECESSARY. THERE WAS NO PATIENT HARM. FURTHER INFORMATION WAS PROVIDED BY THE SURGEON THAT THERE WAS A SCRATCH IN THE MIDDLE OF THE OPTIC, NOTED AFTER INSERTION, AND IS NOT SURE WHAT THE SCRATCH WAS CAUSED BY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800655 ↗
• MalfunctionMar 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A FACILITY REPRESENTATIVE INDICATED THAT "IT LOOKS LIKE THERE IS GLUE AROUND THE EDGES OF THE LENS". ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11532045 ↗
• MalfunctionMar 3, 2021Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT PROCEDURE, THE INTRAOCULAR LENS (IOL) WAS CRACKED AFTER INSERTION IN THE PATIENT'S RIGHT EYE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP IOL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407109 ↗