AcrySof® UltraSert® ACU0T0 (REF ACU0T0.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380652395335), received between Jun 23, 2021 and Dec 24, 2025 — classified as 22 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Failure to Fold; Failure to Fold

  A HEALTHCARE PROFESSIONAL REPORTED THAT LENS APPEARED HARD AND FOLDED UP ON ITSELF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23887125 ↗
• MalfunctionNov 25, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BLOCKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23645426 ↗
• MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIFFICULT TO REMOVE, COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 23503704 ↗
• MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAPTIC WAS NOT COMING OUT CORRECTLY. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496450 ↗
• MalfunctionAug 11, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS TRAPPED UNDER THE PLUNGER AND THEREFORE NOT COMING OUT OF THE INJECTOR. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773252 ↗
• MalfunctionAug 7, 2025Failure to Fold; Failure to Fold

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME TWISTED AFTER BEING ADVANCED AND MADE CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE LENS IMPLANTED SUCCESSFULLY. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739591 ↗
• MalfunctionAug 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS STRAIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22730610 ↗
• MalfunctionJul 30, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE INTRODUCER DID NOT SLIDE ON TOP OF THE LENS. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662885 ↗
• MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE HAPTIC WAS BENT/CRIMPED/DISTORTED/TWISTED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22318877 ↗
• MalfunctionMay 22, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) ANTERIOR HAPTIC DIRECTED FORWARD AND COMPLETELY TWISTED. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT. UNSPECIFIED BACKUP PRODUCT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069297 ↗
• MalfunctionOct 2, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM, ISSUE OCCURRED DURING LOADING WHILE INJECTING IN THE EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349921 ↗
• MalfunctionAug 2, 2023Defective Device; Defective Device

  A NURSING CHIEF REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL CAME DEFECTIVE INTO THE EYE DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ELEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR TEN OF ELEVEN.

  Patient problems: Insufficient Information

  MAUDE report 17441495 ↗
• MalfunctionMay 15, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL), IOL CAME OUT IN STRANGE POSITION AND FOUND TO HAVE POSSIBLE MINOR CRACK IN IOL AFTER IMPLANTATION. THE IOL FOUND TO BE OFF CENTER. THERE WAS NO SIGNIFICANT EFFECT IN VISION. THE PATIENT IS PLANNED TO COME BACK IN 4 WEEKS TO SEE SURGEON FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928809 ↗
• MalfunctionNov 2, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS GOT STUCK IN WOUND DURING INSERTION. AFTER REMOVING LENS FROM WOUND, SURGEON NOTICED OPTIC WAS SCRATCHED. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT, PRODUCT IS NOT AVAILABLE FOR RETURN AS IT IS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15713100 ↗
• MalfunctionAug 24, 2022Failure to Advance; Failure to Advance

  A HEALTH PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS A PROBLEM WITH THE RELEASE OF THE LENSES.

  Patient problems: Insufficient Information

  MAUDE report 15281279 ↗
• MalfunctionJun 15, 2022Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PLUNGER WENT OVER THE LENS. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED BY A BACK UP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692468 ↗
• MalfunctionJun 15, 2022Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PLUNGER WENT OVER THE LENS. THE SURGERY WAS COMPLETED BY USING BACK UP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692393 ↗
• MalfunctionApr 14, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE BROKEN LENS STUCK IN SYRINGE. PATIENT CONTACT IS UNSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14112297 ↗
• MalfunctionJan 4, 2022Break; Break

  AN ACCOUNT MANAGER REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON NOTICED THAT THE TRAILING HAPTIC AND A SMALL PORTION OF THE OPTIC WAS MISSING. THE SURGEON REMOVED THE LENS AND REPLACED WITH SAME MODEL AND POWER LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150506 ↗
• MalfunctionSep 30, 2021Failure to Eject; Failure to Eject

  A NURSE REPORTED THAT THE PLUNGER WENT OVER THE LENS WITH PATIENT CONTACT. SURGERY COMPLETED WITH BY USING A BACK UP PRODUCT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554359 ↗
• MalfunctionJul 27, 2021Inaccurate Delivery; Failure to Eject; Inaccurate Delivery; Failure to Eject

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS. THERE WAS A PATIENT CONTACT WITH NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228120 ↗
• MalfunctionJun 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL WAS FOLDED INSIDE THE INJECTOR WHEN ATTEMPTED TO INSERT INTO PATIENT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047400 ↗