ACRYSOF® SA60WF (REF SA60WF.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652332699), received between Mar 31, 2021 and Jul 31, 2026 — classified as 5 injuries, 16 malfunctions.

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

• InjuryJul 31, 2026Material Opacification

  A physician reported that, following an intraocular lens (IOL) implantation procedure, the lens became opacified. Furthermore reported that there had been no manipulation of the eye since the surgery performed 6 years ago.Additional information has been requested and received stating that they observed an IOL opacification without inciting event and any additional surgeries or procedures in eye since the surgery. There was no further impact to the patient.

  Patient problems: Insufficient Information

  MAUDE report 50101375 ↗
• MalfunctionMay 6, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED TEARS. THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN PATIENT EYE.

  Patient problems: Insufficient Information

  MAUDE report 25094353 ↗
• MalfunctionSep 19, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS MARKED AND NOT INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098174 ↗
• MalfunctionAug 22, 2025Product Quality Problem; Product Quality Problem

  A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTICAL PART OF THE IOL WAS NOTED TO BE BENT. THERE WAS NO PATIENT CONTACT, NO IMPACT ON THE PATIENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872898 ↗
• MalfunctionNov 27, 2024Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF ONE OF THE HAPTICS HAD A DEFECT. THE EDGE OF THE DISTAL TIP WAS FRAYED. DISCOVERED DURING FOLDING OF THE LENS. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798540 ↗
• MalfunctionFeb 24, 2023Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN THE LENS WAS IMPLANTED, A SCRATCH/LINE WAS NOTED UNDER THE MICROSCOPE. THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED IMMEDIATELY AFTER INSERTION WHEN THE SCRATCH WAS SEEN. BACK-UP IOL WAS THEN IMPLANTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 1 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 16434560 ↗
• MalfunctionJan 19, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO HAVE CRACK. THERE WAS PATIENT CONTACT NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16204166 ↗
• MalfunctionOct 21, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED DURING IMPLANTATION AND WAS STUCK IN THE INJECTOR, THE LENS WAS REPLACED IN THE INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT AFFECTING THE COURSE OF THE OPERATION. THE DEFECT WAS DETECTED DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15647452 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT CAN SEE IMPRINTS ON A MEDICINE BOTTLE BUT HE CAN'T SEE ANYTHING FROM FAR. THE PHYSICIAN THINKS THIS MIGHT BE DUE TO ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING HAD BLURRED VISON FOR DISTANCE SINCE HIS SURGERY, HE COULD SEE BETTER AT DISTANCE BEFORE HAVING THE SURGERY. HE CAN READ PILL BOTTLES AND FINE PRINT NOW WITHOUT GLASSES BUT CANNOT SEE TO DRIVE. THOUGHT HE WOULD BE ABLE TO SEE FAR AWAY BUT DISAPPOINTED THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15631193 ↗
• MalfunctionApr 22, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND A STRING ON THE THREE LENSES. THE FACILITY HAS COLLECTED THE ONE STRING IN A JAR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE DAMAGED OPTIC WAS FOUND DURING PLACEMENT OF LENS AND LATER IT TURNS OUT TO BE A STRING WHICH COULD NOT BE REMOVED FROM THE OPTICS DURING INITIAL PROCEDURE. THE STRING WAS SCRAPED OFF THE OPTIC WITH A SWEEP. THE LENS WAS IMPLANTED IN THE PATIENTS EYE.

  Patient problems: Insufficient Information

  MAUDE report 14187368 ↗
• InjuryNov 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT, THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO PATIENT'S HARM INVOLVED. THE VISION WAS GREATLY IMPROVED. PATIENT'S ISSUES WAS RESOLVED.

  Patient problems: Visual Impairment

  MAUDE report 12829080 ↗
• MalfunctionJul 29, 2021Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS IOL OPACIFICATION. THE SURGEON PLANS TO EXCHANGE THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12247552 ↗
• MalfunctionMay 25, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED A DAMAGED INTRAOCULAR LENS (IOL) IMPLANT VIA A REPLY CARD. THE IOL WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11877783 ↗
• MalfunctionMay 13, 2021Defective Device; Defective Device

  A CERTIFIED SURGICAL TECHNICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON ATTEMPTED TO PLACE THE IOL. IT HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT IOL DUE TO A BUBBLE BEING IN THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11820603 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISION WAS TERRIBLE, EVERYTHING WAS WAVY. THE PATIENT WAS TOLD SHE HAD AN EPIRETINAL MEMBRANE MACULAR PUCKER, AND THAT IT COULD ONLY BE CURED BY SURGERY THAT IS CONSIDERED RISKY. APPROXIMATELY 2 YEARS LATER THE PATIENT REPORTED THAT SHE COULD NOT SEE OUT OF THE EYE WHERE THE CATARACT WAS REMOVED. SHE WAS SENT TO SEE A RETINA SPECIALIST, BUT THE DOCTOR WAS NOT SURE WHAT HAD HAPPENED. SHE WAS SENT TO A HOSPITAL FOR AN ANGIOGRAM OF HER EYE. THE DIAGNOSIS WAS AN EPIRETINAL MEMBRANE BUT THE PATIENT BELIEVES THERE WAS SOME DOUBT. SHE CAN SEE FAIRLY WELL WITH BOTH EYES OPEN. WHEN SHE CLOSES THE FELLOW EYE, SHE CANNOT SEE WELL ENOUGH TO READ OR MUCH ELSE. A STRAIGHT LINE IS NOW WAVY AND LETTERS JUMP UP AND DOWN. FURTHER INFORMATION PROVIDED BY THE PATIENT THAT THE EYE WASN'T GOOD AS SOON AS SHE LEFT SURGERY.

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

  MAUDE report 11800968 ↗
• MalfunctionApr 26, 2021Crack; Crack

  A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CRACKED LENS WAS NOTED DURING INSERTION. THE LENS WAS REMOVED AND A BACKUP LENS WAS IMPLANTED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE IOL, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726861 ↗
• MalfunctionApr 21, 2021Material Discolored; Defective Device; Material Discolored; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS HAD A DARK SPOT; AND DURING REMOVAL, THE LENS FELL APART. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LENS. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701346 ↗
• MalfunctionApr 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, A LINE IN THE CENTER OF THE LENS WAS FOUND UPON INSERTION. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679358 ↗
• MalfunctionApr 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, A LINE IN THE CENTER OF THE LENS WAS FOUND UPON INSERTION. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679243 ↗
• MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE HAS REPORTED THAT DURING FIVE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, AND AFTER THE INSERTION OF THE IOL, DEBRIS WAS NOTED. THE DEBRIS WAS CLEARED FROM THE PATIENTS USING I/A. THE LENSES WERE CHECKED UNDER THE MICROSCOPE PRIOR TO INSERTION INTO THE EYE, AND NO DEBRIS COULD BE SEEN. ONLY AFTER IT WAS INSERTED INTO THE EYE COULD IT BE SEEN. THE ORIGINAL PROCEDURE WAS COMPLETED IN ALL INSTANCES AND JUST A FEW MINUTES OF EXTRA TIME WAS USED TO ENSURE THE DEBRIS HAD BEEN CLEARED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATE WITH THIS PHYSICIAN. THIS REPORT IS ASSOCIATED WITH IOL 2 OF 5.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602945 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THERE WAS A CAPSULE TEAR. THE IOL WAS CUT OUT OF THE EYE AND REPLACED WITH A THREE PIECE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11595662 ↗