AcrySof® UltraSert® AU00T0 (UDI 00380652394857)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652394857), received between Jul 28, 2022 and Aug 14, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50251565 ↗
• MalfunctionAug 14, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50250764 ↗
• MalfunctionJul 3, 2026Device Difficult to Setup or Prepare; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE APPLYING THE LENS, THE LAST HAPTIC BECAME CAUGHT IN THE CARTRIDGE. THE LENS WAS NOT PUSHED FORWARD AND HAD TO BE REMOVED AND INSPECTED UNDER A MICROSCOPE. DURING THIS INSPECTION, IT WAS DISCOVERED THAT THE HAPTIC WAS DAMAGED AND THEREFORE COULD NOT BE APPLIED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER UNSPECIFIED LENS ON SAME DAY. THE INITIALLY USED LENS DID NOT COME INTO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703127 ↗
• MalfunctionApr 20, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED STRETCHED HAPTIC. THE PROCEDURE WAS COMPLETED ON 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 24925859 ↗
• MalfunctionMar 9, 2026Break; Failure to Deliver; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE BACK HAPTIC GOT STUCK IN THE INJECTOR AND BROKE OFF INSIDE THE EYE. THE LENS HAD TO BE EXPLANTED, AND A NEW ONE WAS SUCCESSFULLY INSERTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE LENS WAS REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS.

  Patient problems: Insufficient Information

  MAUDE report 24544890 ↗
• MalfunctionDec 26, 2025Failure to Deliver; Failure to Deliver

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS REMAINED IN THE CARTRIDGE DURING THE LOADING PROCESS AND DID NOT COME OUT WITH THE INSERTER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23896553 ↗
• MalfunctionSep 3, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC BROKE DURING INJECTION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGERY WAS COMPLETED BY REPLACING THE LENS WITH NEW IOL. THERE WAS PATIENT CONTACT WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950076 ↗
• MalfunctionMay 29, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE DOING INSERTION OF INTRAOCULAR LENS (IOL), BLUE INSERTER BENT INSIDE OF THE DELIVERY SYSTEM. THE SURGERY WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22106360 ↗
• MalfunctionApr 24, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL DURING SURGERY REPORTED THAT THE LENS STUCK IN DELIVERY SYSTEM AND GET DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED AND IT STATES THAT THE ISSUE WAS NOTICED AFTER FILLING VISCOELASTIC WHEN SURGEON TRIED TO PROCEED THE IOL (INTRAOCULAR LENS) TO INSPECTION LINE. TIP OF THE DEVICE WAS NOT IN CONTACT WITH PATIENT AND PROCEDURE COMPLETED SAME DAY WITH BACKUP LENS WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901053 ↗
• MalfunctionDec 12, 2024Break; Failure to Advance; Break; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, LENS STUCK WITH PLUNGER AND DOCTOR PULL OUT IT CAUSED HAPTIC BROKEN. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LENS DURING INITIAL PROCEDURE WITHOUT COMPLICATION. THERE IS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912062 ↗
• MalfunctionJul 22, 2024Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER MISSED THE LENS, SO THE LENS DID NOT ADVANCE.THE SURGERY WAS COMPLETED WITH A DELAY OF 1-2 MINUTES USING ANOTHER LENS OF THE SAME POWER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19792751 ↗
• MalfunctionJun 19, 2024Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS GOT STUCK IN THE CARTRIDGE. IT COULD NOT BE USED AFTER THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS GOT STUCK IN THE SYRINGE WHEN TRANSFERRING THE LENS INTO THE EYE. THE PART OF THE LENS THAT CAME OUTSIDE THE SYRINGE WAS IN CONTACT WITH THE PATIENT AND THE SYRINGE ITSELF WAS IN CONTACT WITH THE PATIENT. THIS DID NOT AFFECT THE PATIENT AS THE LENS NEVER ENTERED THE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567504 ↗
• MalfunctionJun 18, 2024Crack; Crack

  ANOTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING THE LENS INTO THE EYE IMMEDIATELY NOTICED THAT THE LENS HAD A CRACK. THE LENS WAS REMOVED FROM THE PATIENT'S EYE WITHOUT ISSUES. A NEW LENS WAS IMPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559008 ↗
• MalfunctionJun 3, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT LOAD CORRECTLY IN DEVICE AND UNABLE TO IMPLANT. A NEW LENS WAS OPENED AND IT HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446444 ↗
• MalfunctionMay 22, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BLOCKED. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS. THERE WAS NO DISCOMFORT FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370427 ↗
• MalfunctionApr 10, 2024Defective Device; Defective Device

  HEALTH PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FOUND THE DAMAGED PRE LOADED IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19078673 ↗
• MalfunctionDec 7, 2023Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS STUCK IN INJECTOR AND WAS NOT PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18281815 ↗
• MalfunctionOct 27, 2023Failure to Eject; Failure to Eject

  A PHARMACIST TRAINEE REPORTED THAT AN IMPLANT PASSED UNDER THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18019879 ↗
• MalfunctionApr 25, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT, HAPTIC GOT OUT. ALSO REPORTED THAT 2 TIMES LENS DID NOT PASS AND SUCCEEDED ON THE THIRD TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805404 ↗
• MalfunctionJul 28, 2022Failure to Eject; Failure to Eject

  THE HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE NURSE INJECTS OVD INTO DEVICE AND REMOVES LOCKS, SURGEON ADVANCES PLUNGER AND WATCHED FOLDING THROUGH MICROSCOPE, CONTINUES TO ADVANCE PLUNGER TO INJECT IOL IN THE EYE, AND THE PLUNGER OVERRIDING THE LENS. HAVE HAD TO REMOVE THE FAULTY IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15119581 ↗