ACRYSOF® SN60WF (REF SN60WF.255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380655093306), received between May 3, 2021 and Feb 16, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT LENS WAS CRACKED IN THE CENTER. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS WITH SAME DIOPTER DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24344551 ↗
• MalfunctionMay 9, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INSERTION OF THE IOL (INTRAOCULAR LENS), ITS HAPTIC WAS CUT AT THE TIME THE LENS EXIT FROM THE CARTRIDGE AND THERE WAS A PATIENT CONTACT. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992960 ↗
• MalfunctionMay 6, 2025Scratched Material; Scratched Material

  OTHER HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21967258 ↗
• MalfunctionApr 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE REAR HAPTIC AND INJECTOR TIP ARE STUCK, WHEN TRIED TO SEPARATE THE UNION BETWEEN HAPTIC AND OPTIC WAS TORN. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21764219 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, POSTERIOR CAPSULE RUPTURED WITH ZONULOLYSIS WAS NOTICED. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT IN SURGEONS OPINION SURGEON WAS UNSURE WHETHER ITS RELATED TO IOL OR ANATOMY.

  Patient problems: Capsular Bag Tear; Zonular Dehiscence

  MAUDE report 20759006 ↗
• MalfunctionNov 14, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED STATING SCRATCH WAS OBSERVED UNDER THE MICROSCOPE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689304 ↗
• MalfunctionNov 8, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS GETS TRAPPED IN INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20638003 ↗
• MalfunctionSep 5, 2024Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CARTRIDGE BECAME OBSTRUCTED, RUPTURED, AND BLOCKED THE PASSAGE OF THE IOL. THE SURGERY WAS COMPLETED BY USING ANOTHER LENS AND CARTRIDGE OF SAME MODEL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146568 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT TWO YEARS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED LECOG/POSSIBLE PHIMOSIS IN THE EYES. THE SURGEON PERFORMED POSTERIOR AND ANTERIOR YTTRIUM-ALUMINUM-GARNET LASER (YAG) CAPSULOTOMIES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Fibrosis

  MAUDE report 18408141 ↗
• MalfunctionMar 10, 2023Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  A PHYSICIAN ASSISTANT REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION, THE TRAILING HAPTIC WAS TORN. THE LENS WAS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT CRACK LENS WAS NOTED AT LENS HAPTIC LEG AND TEMPORAL LEG IS FIRMLY ATTACHED AND THE TEAR WAS NOTICED DURING IMPLANTATION. NO FURTHER INFORMATION AVAILABLE. THERE ARE 7 MEDICAL DEVICE REPORTS ASSOCIATED. THIS REPORT IS 2 OF 7.

  Patient problems: Insufficient Information

  MAUDE report 16520340 ↗
• InjuryAug 3, 2022Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, LENS FOUND TO HAVE LONG LINEAR SCRATCH ON THE POSTERIOR FACE OF THE OPTIC, RIGHT THROUGH THE VISUAL AXIS IMMEDIATELY AFTER INJECTION. SCRATCHES ARE ORIENTED 6-12 O¿CLOCK. UPON INJECTION, THE SCRATCH WAS AT 3-9 O¿CLOCK, BUT WHEN POSITIONED THE LENS INTO THE BAG, SURGEON ROTATED IT ABOUT 90 DEGREES CLOCKWISE TO ARRIVE AT THE 6-12 ORIENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15154794 ↗
• MalfunctionJun 14, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE PROCEDURE WAS NOT GONE WELL AND THEY PUT THE LENS BACK IN THE CARTRIDGE. ON THE SECOND OCCASION THE LENS WAS IMPLANTED AND ROTATED CORRECTLY. THREE DAYS FOLLOWING THE PROCEDURE THE PATIENTS VISUAL ACUITY DID NOT IMPROVE. WHEN CHECKED IN THE LAMP OF SLIT, THE HAPTIC WAS BROKEN FOR WHICH THE LENS NEEDS TO BE REMOVED. DURING THE SURGERY IT WAS NOT OBSERVED, IN FACT THE LENS WAS ROTATED AND IT DID NOT LOOK BROKEN.

  Patient problems: Visual Disturbances

  MAUDE report 14685049 ↗
• MalfunctionNov 23, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOLDED UP AS THEY WERE INSERTING. THERE WAS PATIENT CONTACT WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Insufficient Information

  MAUDE report 12860099 ↗
• MalfunctionMay 3, 2021Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE LENS HAD A CRACK LOCATED 90 DEGREES FROM THE HAPTIC. THE LENS REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT HARM AND THE SURGEON BELIEVES THAT THERE WILL NOT BE ANY NEGATIVE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766451 ↗