AcrySof® UltraSert® AU00T0 (UDI 00380652394888)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652394888), received between Mar 23, 2021 and Jan 6, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another 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 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.

• MalfunctionJan 6, 2026Device Difficult to Setup or Prepare; Inaccurate Delivery

  A PHARMACIST REPORTED WITH DESCRIPTION THAT DURING PROCEDURE WHEN THE LENS WAS DESTERILIZED, THE SURGEON NOTICED PROBLEM WHILE INJECTING THE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS NOT COMPLETELY INSIDE THE EYE. THE PROCEDURE WAS COMPLETED USING REPLACEMENT LENS.

  Patient problems: Insufficient Information

  MAUDE report 23973606 ↗
• MalfunctionOct 17, 2025Defective Component; Defective Component

  A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR TIP WAS UNSTABLE AND DETACHES/FALLS OFF DURING USE. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE, USED ANOTHER IMPLANT. THE MEDICAL DEVICE DIDN'T TOUCH THE PATIENT'S EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323093 ↗
• MalfunctionJul 22, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device

  AN ADMINISTRATOR/SUPERVISOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS, DAMAGING BOTH LENS AND THE POSTERIOR HAPTICS WITH NO PATIENT CONTACT, AND CONSEQUENTLY THE LENSES COULD NOT BE INSERTED. THE SURGERY WAS COMPLETED WITH A SECOND LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566181 ↗
• InjurySep 24, 2024Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HE HAD TO WIDEN THE INCISION FOR EVERY SUSPECT DEVICE USED. THE SURGEON STATED THAT THE USUAL INCISION SIZE WAS 2.4 MM, BUT THIS WASN'T ENOUGH FOR THE SUSPECT DEVICE, SO HE HAD TO WIDEN THE INCISION TO 2.5 TO 2.6 MM TO INSERT THE CARTRIDGE TIP INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT, BUT NO IMPACT ON THE PATIENT AS THE CATARACT OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS AFTER THE INCISIONS WERE WIDENED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 7 OF 7.

  Patient problems: Eye Injury

  MAUDE report 20291654 ↗
• InjuryJul 29, 2024Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON INJECTS THE LENS INTO THE POSTERIOR CHAMBER BAG IN THE LEFT EYE. WHILE INSIDE THE EYE, THE INTRAOCULAR LENS WAS DETECTED THAT A HANDLE (HAPTIC) WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED, THE INCISION WAS EXPANDED IN THE MAIN PORT WITH A KNIFE FOR IOL EXPLANTATION DURING INITIAL PROCEDURE AND THE PATIENT WAS RECOVERED.

  Patient problems: Eye Injury

  MAUDE report 19850523 ↗
• MalfunctionJul 9, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS MISFIRED AND DID NOT COME OUT THE INJECTOR PROPERLY AT TIME OF SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19701122 ↗
• MalfunctionJun 13, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PISTON WENT OVER THE LENS AND DAMAGED IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19528605 ↗
• MalfunctionJan 19, 2024Defective Device; Defective Device

  A PHARMACY STUDENT REPORTED FAILURE PLACEMENT WITH THE INTRAOCULAR LENS (IOL) IMPLANT DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18542177 ↗
• MalfunctionSep 4, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE DUE TO INJECTOR FAILURE. ALSO, THE TWO HAPTICS WERE FOLDED CORRECTLY BUT WHEN INJECTED INSIDE ONE OF THE HAPTICS WAS FRACTURED. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT HAD RIGHT EYE PHACO SURGERY. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676782 ↗
• MalfunctionMar 13, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION ON THE THIRD TRY THE LENS ADVANCED SMOOTHLY AND THE LENS WAS IMPLANTED. THE NURSE THOUGHT SHE HAD SEEN SMALL SCRATCH ON THE SURFACE OF THE LENS. IT WAS ALSO INSTRUCTED THAT THE LENS SHOULD NOT BE USED IF THE PLUNGER GOES ABOVE THE LENS. THERE WAS CONTACT WITH THE PATIENT AND THE LENS REMAINED IMPLANTED. THERE WAS NO PATIENT HARM AND HOSPITALIZATION OR INTERVENTION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH THE SAME LENS, NO REPLACEMENT LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13751376 ↗
• MalfunctionMar 23, 2021Failure to Advance; Failure to Advance

  THERE WAS NO CONTACT BETWEEN THE DEVICE AND THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556452 ↗