AcrySof® UltraSert® ACU0T0 (REF ACU0T0.260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652395373), received between Aug 23, 2022 and Sep 15, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device Damaged by Another Device

  A health care professional reported with the description of rift/damaged edge on the Intraocular lens (IOL).Additional information received and stated that IOL was implanted without any complications. It was also stated that the issue was noted when the IOL was just implanted in the eye.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775795 ↗
• MalfunctionAug 13, 2026Product Quality Problem

  Patient problems: Insufficient Information

  MAUDE report 50233331 ↗
• MalfunctionApr 1, 2026Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY HAPTIC PROBLEM WAS IDENTIFIED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE EVENT WAS DESCRIBED AS A STRAIGHT HAPTIC PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 5.

  Patient problems: Insufficient Information

  MAUDE report 24751427 ↗
• MalfunctionJul 23, 2025Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS DID NOT PROGRESS FORWARD AND THE PLUNGER WENT OVER IT. SURGERY SLIGHTLY DELAYED AS A NEW LENS WAS COLLECTED, IT WAS COMPLETED SAFELY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577075 ↗
• MalfunctionMay 16, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE TRAILING HAPTIC WAS BROKEN DURING THE IMPLANTATION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT OPHTHALMOLOGY REQUESTED IOL CUTTER AND THE LENS WITH THE BROKEN TRAILING HAPTIC WAS CUT INTO PIECES AND REMOVED FROM THE PATIENT EYE AND THE SURGERY WAS COMPLETED WITH NEW REPLACEMENT LENS WITH NO PATIENT HARM. THE LENS WAS DISCARDED AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034474 ↗
• MalfunctionJan 10, 2025Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS TRAILING HAPTIC WAS STUCK IN THE INJECTOR, AND LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER LENS. 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 21123145 ↗
• MalfunctionNov 5, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY LENS OPENING SIDEWAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 20608393 ↗
• MalfunctionAug 13, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR. THERE WAS PATIENT CONTACT . THE PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974850 ↗
• MalfunctionJun 10, 2024Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT PUSH THE LENS BUT SLIPPED UNDERNEATH NOT ALLOWING THE LENS TO COME OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19496554 ↗
• MalfunctionMay 23, 2023Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE IOL WAS LEFT IN THE EYE WITH THE 2 SCRATCHES, CURRENTLY THE PATIENT HAS NO PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 16982189 ↗
• MalfunctionNov 7, 2022Defective Device; Scratched Material; Defective Device; Scratched Material

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION ON INSERTING THE LENS, THE LENS DELIVERY SYSTEM DID NOT OFFER ANY RESISTANCE AND THE SURGEON WAS SHOCKED AS TO HOW QUICKLY THE LENS CAME OUT OF THE INJECTOR. THERE APPEARED TO BE NO DAMAGE TO THE PATIENT, HOWEVER ON THE LENS OPENING UP, THERE WAS A SCRATCH ON THE LENS WHICH WAS IN THE CENTER OF THE PATIENTS' VISION. THE SURGEON FELT THIS COULD NOT BE LEFT IN PLACE AS IT WOULD HAVE AFFECTED THE PATIENT IMMENSELY AFTER SURGERY. THE LENS WAS CUT IN HALF INSIDE THE EYE, REMOVED, AND REPLACED. ALTHOUGH IT DID COME IN TO CONTACT WITH THE PATIENT, NO HARM WAS CAUSED TO THE PATIENT, DESPITE A LONGER SURGERY TIME. THE OPERATION WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742013 ↗
• MalfunctionAug 23, 2022Failure to Fold; Defective Device; Failure to Eject; Failure to Fold; Defective Device; Failure to Eject

  A NON-HEALTH PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES SEEM TO BE TOO HARD AND WERE NOT COMING OUT IN THE CORRECT POSITION. ADDITIONAL INFORMATION WAS RECEIVED STATING THE TIP OF THE LENS DISPENSER CAME INTO CONTACT WITH THE PATIENT BUT THERE WAS NO HARM DONE TO THE PATIENT. IN REGARD TO LENSES NOT COMING OUT IN THE CORRECT POSITION, WE RECEIVED CLARIFICATION AND IT REFERS TO THE LENSES WOULD GET STUCK ON THE TIP OF THE DELIVERY DEVICE AND THEN GO BACK IN, SURGEON ASSUMES IT¿S BECAUSE THE LENSES WERE NOT FOLDING PROPERLY OR THE LENSES WERE TOO HARD. ALL PROCEDURES WERE DONE WITH BACK-UP LENSES. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278066 ↗