AcrySof® UltraSert® AU00T0 (UDI 00380652394673)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652394673), received between Dec 24, 2021 and Nov 7, 2025 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE INJECTOR SLID OVER THE LENS DUE TO WHICH LENS WAS DAMAGED. THE LENS WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 23497420 ↗
• MalfunctionOct 21, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DISPENSING MECHANISM FOR LENS FAILED. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23347492 ↗
• MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DID NOT PROCEED CORRECTLY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES DURING THE PROCEDURE, THE INJECTOR HAD PATIENT CONTACT BUT NOT THE LENS, AS IT WOULD NOT PROCEED, REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS ON SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 21863966 ↗
• MalfunctionFeb 25, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT, A FAULTY INTRAOCULAR LENS (IOL) PLUNGER DID NOT ENGAGED AND GOT BENT AFTER PUSHING IT THROUGH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21457267 ↗
• MalfunctionDec 13, 2023Failure to Fold; Defective Device; Failure to Fold; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED AND PHYSICIAN STATED THAT THE LENSES DIDN¿T FOLD WELL AND HE WASN¿T COMFORTABLE IMPLANTING THEM.

  Patient problems: Insufficient Information

  MAUDE report 18317954 ↗
• MalfunctionJul 17, 2023Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PLUNGER WAS DEFECTIVE AND LENS WAS ALSO REPORTED TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED AND IT WAS FURTHER CLARIFIED THAT THE LENS WAS NOT ABLE TO BE DEPLOYED. THIS HAPPENED DURING THE SURGERY AND THE IMPLANT WAS IN CONTACT WITH THE PATIENT. AS PER THE SURGEON OPINION THE PRODUCT HAD CONTRIBUTED O THE EVENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332613 ↗
• MalfunctionMar 11, 2022Optical Decentration; Device Damaged by Another Device; Failure to Eject; Optical Decentration; Device Damaged by Another Device; Failure to Eject

  A PHYSICIAN REPORTED DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS IMPLANT PROCEDURE, DIFFICULTY ENCOUNTERED DURING INJECTION. THE SURGEON MOVED THE PLUNGER UP A LITTLE TO REINJECT CORRECTLY, AT WHICH POINT THE PROXIMAL HAPTIC WAS FOUND TO BE MISSING, TORN AT THE BASE OF THE JUNCTION WITH THE OPTIC. THE SURGEON DECIDED TO LEAVE THE IMPLANT IN THE CAPSULAR BAG AND TO FINISH THE SURGERY NORMALLY WITH THE ADDITION OF MIOSTAT AT THE VERY END OF THE SURGERY TO CONTRACT THE IRIS AND MAINTAIN THE IMPLANT IN THE BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13732977 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED AQUEOUS CELL, AQUEOUS FIBRIN, HYPOPYON, CONJUNCTIVAL INFLAMMATION. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC, STEROID AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVING WITH TOPICAL MEDICATION. THIS IS THE FIRST OF THREE REPORTS FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypopyon; Inflammation; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13722844 ↗
• MalfunctionDec 24, 2021Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN INSERTER WAS INJECTED HARD GOING INTO THE EYE, THE LENS DID NOT COME OFF THE INSERTER. THERE WAS PATIENT CONTACT WITH THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13084838 ↗