AcrySof® UltraSert® AU00T0 (UDI 00380652394659)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652394659), received between Aug 22, 2022 and Dec 4, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAPTIC BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LEADING HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714596 ↗
• MalfunctionNov 11, 2025Failure to Advance; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS STUCK IN CARTRIDGE / LENS WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23522262 ↗
• MalfunctionMar 5, 2025Material Deformation; Material Deformation

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DAMAGED DURING LOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21526346 ↗
• MalfunctionFeb 18, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER STUCK WITH UNABLE TO ADVANCE THE LENS. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21393230 ↗
• MalfunctionFeb 10, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PREFILLED WITH NON-COMPANY VISCOELASTIC BEFORE ADMINISTERING TO THE PATIENT. THE LENS GOT CAUGHT IN BETWEEN THE EYE AND THE CARTRIDGE. WHEN DOCTOR WAS PULLING IT OUT, THE HALF OF THE LENS WAS IN THE EYE AND HALF OUT OF THE EYE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21342753 ↗
• InjurySep 20, 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 5 OF 7.

  Patient problems: Eye Injury

  MAUDE report 20268703 ↗
• MalfunctionFeb 20, 2024Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject

  AN OPTOMETRIST REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE PATIENT'S EYE, IT WAS SPLIT. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. WHEN LOADING THE LENS THE INSERTER'S PISTON INITIALLY SLID OVER THE LENS. THE PISTON WAS PULLED BACK AND PUSHED AGAIN, CAUSING THE REAR HAPTIC TO REMAIN STRAIGHT ON TOP OF THE PISTON. IT WAS SHOWN TO THE DOCTOR, AND THE DOCTOR DECIDED TO PROCEED WITH USING THE LENS. THERE WERE PROBLEMS WITH THE HAPTIC, THEREFORE, THE SURGEON HAD TO CUT THE LENS, REMOVE IT AND USE ANOTHER LENS IN SAME PROCEDURE. THIS PROLONGED THE SURGERY TIME. THE REMOVED LENS WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 18737450 ↗
• MalfunctionMar 10, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS UNFOLDED INCORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT, THIS IS 1 OF THE 2 FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520497 ↗
• MalfunctionAug 22, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STIFF. ADDITIONAL INFORMATION WAS RECEIVED AND STATED LENS WAS EXCHANGED WITH ANOTHER LENS. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265189 ↗