AcrySof® UltraSert® AU00T0 (UDI 00380652394697)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652394697), received between May 4, 2021 and Jun 2, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (5 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.

• InjuryJun 2, 2026Failure to Fold; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BECAME TRAPPED BETWEEN THE PLUNGER AND THE IOL INJECTOR, BETWEEN THE BLUE AND TRANSPARENT COMPONENTS. IT APPEARED THAT THE IOL HAD NOT FOLDED CORRECTLY. UNFORTUNATELY, IT WAS NOTICED ONCE THE IOL WAS ALREADY IN THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. FORTUNATELY, THERE WERE NO COMPLICATIONS APART FROM A SMALL IRIS BLEED RELATED TO THE EXPLANATION. THE PATIENT IS IN VERY GOOD CONDITION WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hyphema

  MAUDE report 25360595 ↗
• MalfunctionApr 20, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THE HAPTIC WAS STRETCHED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE EVENT OCCURRED BEFORE IMPLANTATION AND NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING BACK UP LENS WITH NO FURTHER CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925857 ↗
• MalfunctionDec 8, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK AT THE END OF INJECTOR AND UNABLE TO IMPLANT WITH NO PATIENT CONTACT. SURGEON IMPLANTED 3-PIECE LENS INSTEAD. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735883 ↗
• MalfunctionJul 8, 2025Break; Break

  A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAPTIC WAS BROKEN DURING PREPARATION. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436033 ↗
• MalfunctionMar 4, 2024Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION LENS DID NOT DEPLOY AS EXPECTED WITH NO REPORTED PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825175 ↗
• MalfunctionMay 25, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON SLOWLY ADVANCED THE PLUNGER, IT WENT THROUGH ON TOP OF THE LENS AND APPARENTLY SCRATCHED THE OPTIC. THE PHYSICIAN USED HIS BACKUP LENS INSTEAD. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003460 ↗
• MalfunctionJul 27, 2022Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS OVERRIDE THE IOL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15113605 ↗
• MalfunctionJun 24, 2021Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS GET STUCK IN INJECTOR AND SYRINGE WENT OVER THE LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM REPORTED. THE REPORTER IS UNWILLING TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055989 ↗
• MalfunctionJun 24, 2021Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS GET STUCKED IN INJECTOR AND SYRINGE WENT OVER THE LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM REPORTED. THE REPORTER IS UNWILLING TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055988 ↗
• MalfunctionMay 10, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  A FACILITY REPRESENTATIVE REPORTED VIA AN IOL REPLY CARD THAT AN INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE IT DID NOT UNFOLD RIGHT. THIS INFORMATION WOULD INDICATE PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797635 ↗
• MalfunctionMay 4, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS DID NOT UNFOLD PROPERLY. THE LENS WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769663 ↗