AcrySof® UltraSert® ACU0T0 (REF ACU0T0.255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652395366), received between Jul 2, 2021 and Feb 16, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Scratched Material

  A PHARMACIST REPORTED WITH A DESCRIPTION, THE LENS DISC WAS SCRATCHED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SCRATCH WAS DETECTED DURING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343769 ↗
• MalfunctionNov 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC DID NOT COME OUT CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507061 ↗
• MalfunctionOct 24, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE UPON INSERTION OF THE IOL INTO THE PATIENT'S EYE, THE TRAILING HAPTIC WAS FOUND TO BE BROKEN AND REMAINED LODGED WITHIN THE LENS INTRODUCER. AS A RESULT, THE IMPLANTED LENS HAD TO BE CAREFULLY CUT AND REMOVED. A NEW IOL WAS INSERTED WITHOUT COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380434 ↗
• MalfunctionJul 17, 2025Failure to Advance; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OVERRODE THE LENS. THERE WAS NO PATIENT HARM. THE SURGERY COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533534 ↗
• MalfunctionApr 23, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE INJECTOR WENT OVER THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889381 ↗
• InjuryOct 24, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INJECTED AND UNFORTUNATELY ONCE OPENED IN THE EYE IT WAS NOTICED THAT THE LENS HAD A LARGE CRACK IN THE CENTER. THE LENS REMOVED AND REPLACED AND THERE WAS NO COMPLICATIONS. IN FOLLOW-UP VISIT THE SURGEON OBSERVED CORNEAL EDEMA DUE TO PROLONGED SURGERY AND ONLY ABLE TO VISUALLY COUNT FINGERS AND TREATMENT WAS GIVEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT HAD SUTURE OF WOUND.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 20520672 ↗
• MalfunctionFeb 2, 2024Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.

  Patient problems: Insufficient Information

  MAUDE report 18629088 ↗
• MalfunctionAug 14, 2023Break; Failure to Eject; Break; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT INJECT PROPERLY INTO THE EYE, PART OF THE LENS WAS STILL IN THE DELIVERY SYSTEM. THE LEADING HAPTIC WAS RIPPED AND IT WAS STILL IN THE DELIVERY SYSTEM. THE SURGERY WAS COMPLETED WITH ANOTHER LENS.

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

  MAUDE report 17540379 ↗
• MalfunctionAug 4, 2023Defective Device; Defective Device

  A NURSING CHIEF REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL CAME DEFECTIVE INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ELEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR 11 OF 11.

  Patient problems: Insufficient Information

  MAUDE report 17456619 ↗
• MalfunctionJul 13, 2021Failure to Advance; Failure to Advance

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS WAS STUCK IN THE PISTON AND IN ORDER TO INSERT IT INTO THE PATIENT'S EYE, THE SURGEON HAD TO HOLD IT USING THE CANNULA. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159448 ↗
• MalfunctionJul 2, 2021Failure to Deliver; Difficult to Advance; Failure to Eject; Physical Resistance/Sticking; Failure to Deliver; Difficult to Advance; Failure to Eject; Physical Resistance/Sticking

  A SAFETY MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS DELIVERY FAILED. THE SURGEON NOTICED THE RESISTANCE IN THE INJECTOR, THE INJECTOR ARM DID NOT ENGAGE THE LENS AND PASSED OVER THE IOL. THERE WAS A PATIENT CONTACT WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108885 ↗