ACRYSOF® SA60WF (REF SA60WF.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652332682), received between Mar 26, 2021 and May 6, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS THAT WERE IMPLANTED CAREFULLY INSPECTED BEFORE LOADING. NO TEARS WERE OBSERVED AT THAT STAGE. HOWEVER, AFTER THE LENS UNFOLDED IN THE PATIENT¿S EYE, A SIGNIFICANT TEAR WAS SEEN. THIS MEANS THAT THE TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. THEY TRIED USING EXTRA VISCOELASTIC, WHICH FEELS BETTER, BUT THIS HAD NOT PREVENTED NEW TEARS FROM OCCURRING. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED AT ALL, AND ALL CONTACT WAS MADE ONLY WITH THE ¿HAPTICS/LEGS¿. DESPITE THIS, THE LENS SHOWED TEARS ACROSS THE OPTIC ONCE THEY UNFOLDED INSIDE THE EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN PATIENT EYE.

  Patient problems: Insufficient Information

  MAUDE report 25107427 ↗
• MalfunctionOct 24, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS DAMAGED/BROKEN DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS HAPTICS WAS COMPLETELY BROKEN BEFORE ATTEMPTED TO LOAD IT. SURGERY WAS COMPLETED WITH A NEW LENS. THERE ARE TWO COMPLAINTS ASSOCIATED WITH THIS REPORT. THIS FILE IS FOR FIRST LENS.

  Patient problems: Insufficient Information

  MAUDE report 23378626 ↗
• MalfunctionOct 17, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INSERTION OF THE IOL INTO POSTERIOR BAG, NOTED ONE OF THE HAPTIC BROKEN WHILE IMPLANTED IN THE EYE. REPLACED WITH BACK UP LENS TO CONTINUE AND COMPLETED THE SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS IMPLANTED AND EXPLANTED DURING THE INITIAL PROCEDURE AND REPLACED WITH BACK UP LENS.

  Patient problems: Insufficient Information

  MAUDE report 23331466 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE POSTERIOR CAPSULE RUPTURED WHEN IMPLANTING THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE POSTERIOR CAPSULE TEAR HAPPENED WHEN SURGEON TRIED TO DIAL THE LENS INTO THE BAG.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062349 ↗
• MalfunctionAug 2, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, LENS HAD A LINEAR CRACK FROM THE MIDDLE UP TO THE OPTIC HAPTIC JUNCTION WHICH WAS NOTED UPON INSERTION. THERE WAS NO DIFFICULTY WHEN FOLDING AND INSERTING THE IOL. THE SURGEON DECIDED TO LEAVE THE IOL INSIDE THE PATIENT¿S EYE AS PATIENT HAD ACUTE MACULAR DEGENERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19891130 ↗
• MalfunctionJun 11, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS LOADED FINE AND WHEN THE DOCTOR WENT TO DEPLOY THE LENS IT UNFOLDED BACKWARDS, AND HAD TO BE REMOVED FROM THE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19508569 ↗
• MalfunctionJul 5, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A FACILITY REPRESENTATIVE REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD FOLDING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT UNFOLD. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS DURING THE INITIAL IMPLANT PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257294 ↗
• MalfunctionMay 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WAS A STRING OF LENS MATERIAL THAT WAS JUST NEXT TO THE HAPTIC WHICH COULD NOT BE REMOVED AND WAS ATTACHED TO THE OPTIC, THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17017258 ↗
• MalfunctionOct 12, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) FIBROUS TISSUE (LOOKING LIKE A SCRATCH ON THE POSTERIOR OPTIC) APPEARED AFTER THE IOL IMPLANTATION. THE SURGERY WAS COMPLETED THE SAME DAY. NO INFORMATION ABOUT LENS REMOVAL OR REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT CONDITION IS UNKNOWN. THE LENS IS STILL IMPLANTED IN THE PATIENT'S EYE.

  Patient problems: Insufficient Information

  MAUDE report 15585139 ↗
• MalfunctionJun 30, 2022Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REMOVING THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14873217 ↗
• MalfunctionMay 31, 2022Defective Device; Defective Device

  AN ADMINISTRATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WAS DAMAGED AND HAD TO BE CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14546523 ↗
• MalfunctionMay 29, 2022Break; Failure to Eject; Break; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A RUPTURE OF LOOP, THAT LEAD TO THE IMPOSSIBILITY OF IMPLANTATION. IT WAS REPORTED THAT THE BREAKING OF THE LENS CAUSED BY THE NEED TO REMOVE THE LENS STUCK IN THE SURGICAL TUNNEL, AS DURING THE IMPLANTATION THE PATIENT WITH AN UNCONTROLLED MOVEMENT MOVED THE HEAD DURING THE IMPLANTATION PHASE, FREEING THE SURGICAL BREACH FROM THE INJECTOR, THAT LEADS TO THE INCARCERATION OF THE OPTIC BODY IN THE SURGICAL TUNNEL. THE SURGEON REMOVED THE LENS TO RELOAD IT IN THE COMPANY CARTRIDGE, BUT HE BROKE A LOOP BY PULLING. HE REPLACED THE LENS, WHICH IN ANY CASE DID NOT ENTER THE ANTERIOR CHAMBER, AND COMPLETED THE SURGERY WITHOUT ANY CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT OPTIC PLATE WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538701 ↗
• MalfunctionApr 26, 2022Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS AND WHICH WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14204782 ↗
• MalfunctionFeb 18, 2022Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS FAULTY, MELTED AND DEFORMED AS A RESULT IT COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13560135 ↗
• InjuryJul 29, 2021Material Opacification; Material Opacification

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE BY A ANOTHER LENS.

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

  MAUDE report 12247170 ↗
• MalfunctionJul 27, 2021Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON OBSERVED A DIVET ON THE POSTERIOR SIDE OF THE LENS, AS WELL AS SOME WHITE MATERIAL ON THE DIVET. DOES NOT APPEAR TO HAVE BEEN CAUSED DURING LOADING. LENS WAS REMOVED FROM PATIENT¿S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230944 ↗
• MalfunctionApr 12, 2021Scratched Material; Scratched Material

  A PHYSICIAN REPORTED A SCRATCH ON AN INTRAOCULAR LENS (IOL). THERE WAS CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11648270 ↗
• MalfunctionMar 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS UNIDENTIFIED PLASTIC LIKE MATERIAL BEHIND THE LENS AFTER INSERTION. ADDITIONAL INFORMATION WAS PROVIDED THAT IT APPEARED THERE WAS A FINE THIN BLUE LINE BEHIND THE LENS. THE SURGEON REMOVED THE DEBRIS WITH AN IRRIGATION/ASPIRATION DEVICE. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FACILITY. THIS REPORT IS ASSOCIATED WITH 2 OF 3.

  Patient problems: Foreign Body In Patient

  MAUDE report 11574643 ↗