AcrySof® UltraSert® ACU0T0 (REF ACU0T0.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652395250), received between Apr 7, 2021 and Sep 18, 2026 — classified as 3 injuries, 24 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. 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Scratched Material

  A healthcare professional reported that during a cataract surgery with intraocular lens (IOL) implant procedure, once the lens had been loaded within the patient's eye, the surgeon noticed a small scratch on the lens running down the middle of it. The lens was explanted during initial procedure. The surgery was completed on the same day using another unspecified lens without any harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814631 ↗
• MalfunctionApr 9, 2026Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING PRIMING, THE POSTERIOR HAPTIC WAS EXTENDED AND RAN STRAIGHT NEXT TO THE STAMP. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. 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 24825535 ↗
• MalfunctionOct 24, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN THE INJECTOR. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377012 ↗
• MalfunctionSep 2, 2025Failure to Fold; Device Damaged by Another Device; Failure to Fold; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS REALLY HARD. HAPTIC BROKEN DURING INSERTION. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED WITH BACKUP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936114 ↗
• MalfunctionAug 6, 2025Device Difficult to Setup or Prepare; Failure to Prime; Failure to Deliver; Failure to Advance; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Failure to Prime; Failure to Deliver; Failure to Advance; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED THAT IOL BECAME WEDGED BETWEEN PLUNGER AND INJECTION CANNULA. IN SURGEON¿S OPINION THE INCREASED RESISTANCE WHEN PRESSED THE PLUNGER AND STOPPED WHEN NOTICED THE IOL/PLUNGER MISHAP WAS THE CAUSE OF THE EVENT.

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

  MAUDE report 22731095 ↗
• MalfunctionJul 4, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LENS WAS PLACED INTO THE PATIENT'S EYE, THE SURGEON OBSERVED THAT ONLY ONE HAPTIC WAS PRESENT. AS A RESULT, HE REMOVED THE DAMAGED LENS AND PROCEEDED WITH IMPLANTATION OF ANOTHER COMPANY LENS. UPON INSPECTING THE DEVICE IT WAS FOUND THAT THE TRAILING HAPTIC WAS PRESENT IN THE TIP OF THE INTRODUCER IN VISCOELASTIC. THERE WAS NO HARM WAS CAUSED TO THE PATIENT AS A RESULT OF THE LENS ISSUE, AND THE PATIENT WAS INFORMED ABOUT THE INCIDENT FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402922 ↗
• MalfunctionApr 1, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) PRIMING, LENS STUCK IN DELIVERY SYSTEM AND TRAILING HAPTIC FOLDED WRONG. LENS DID NOT COME OUT, IT WAS BLOCKED. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740294 ↗
• InjurySep 24, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HE HAD TO WIDEN THE INCISION FOR EVERY SUSPECT DEVICE USED. THE SURGEON STATED THAT THE USUAL INCISION SIZE WAS 2.4 MM, BUT THIS WAS NOT ENOUGH FOR THE SUSPECT DEVICE, SO HE HAD TO WIDEN THE INCISION TO 2.5 TO 2.6 MM TO INSERT THE CARTRIDGE TIP INTO THE PATIENT EYE. THERE WAS PATIENT CONTACT, BUT NO IMPACT ON THE PATIENT AS THE CATARACT OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS AFTER THE INCISIONS WERE WIDENED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 7.

  Patient problems: Eye Injury

  MAUDE report 20292307 ↗
• MalfunctionApr 8, 2024Defective Device; Scratched Material; Defective Device; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MARK/SCRATCH ON THE LENS NEAR TO THE EDGE. IT WAS NEAR TO THE EDGE SO WOULD NOT ABLE TO EXPLANT. LENS STILL IMPLANTED IN PATIENTS EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19058610 ↗
• MalfunctionMar 15, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE DEVICE WAS NOT USED.

  Patient problems: Insufficient Information

  MAUDE report 18913490 ↗
• MalfunctionDec 6, 2023Crack; Unintended Ejection; Failure to Unfold or Unwrap; Defective Component; Failure to Advance; Crack; Unintended Ejection; Failure to Unfold or Unwrap; Defective Component; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DOES NOT SEEM TO BE OPENING PROPERLY, WAS GOING IN UPSIDE DOWN, THE HAPTIC WAS BREAKING OFF. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGERY WAS COMPLETED USING ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 18272988 ↗
• MalfunctionDec 6, 2023Crack; Failure to Unfold or Unwrap; Defective Component; Failure to Advance; Crack; Failure to Unfold or Unwrap; Defective Component; Failure to Advance

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH AN ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 18272987 ↗
• MalfunctionJun 12, 2023Failure to Eject; Failure to Eject

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT COME OUT OF THE CARRIAGE IN THE NORMAL WAY, BUT POPPED OUT LIKE A DRAIN OUT AND FORWARD FROM THE FRONT HAPTIC AND WHICH WAS HAPPENED FOR 4 LENSES. IN THE CASE OF ONE LENS, THE REAR HAPTICS ALSO POPPED OUT ON THE SAME WAY. THE LENS CANNOT BE PLACED SAFELY ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, SURGEON ITSELF PREFILLED THE LENS AND THE FRONT OPTIC DID NOT COME OUT OF THE SLED NORMALLY. POPPING UP EARLY LIKE A CADUCEUS AND COULD NOT BE PLACED ON THE PATIENT AT ALL. ONE OF THE LENSES ALSO HAD THE SAME PROBLEM WITH THE LOWER OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 17106092 ↗
• MalfunctionJun 12, 2023Failure to Eject; Failure to Eject

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT COME OUT OF THE CARRIAGE IN THE NORMAL WAY, BUT POPPED OUT LIKE A DRAIN OUT AND FORWARD FROM THE FRONT HAPTIC AND WHICH WAS HAPPENED FOR 4 LENSES. IN THE CASE OF ONE LENS, THE REAR HAPTICS ALSO POPPED OUT ON THE SAME WAY. THE LENS CANNOT BE PLACED SAFELY ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, SURGEON ITSELF PREFILLED THE LENS AND THE FRONT OPTIC DID NOT COME OUT OF THE SLED NORMALLY. POPPING UP EARLY LIKE A CADUCEUS AND COULD NOT BE PLACED ON THE PATIENT AT ALL. ONE OF THE LENSES ALSO HAD THE SAME PROBLEM WITH THE LOWER OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 17106090 ↗
• MalfunctionJun 12, 2023Failure to Eject; Failure to Eject

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT COME OUT OF THE CARRIAGE IN THE NORMAL WAY, BUT POPPED OUT LIKE A DRAIN OUT AND FORWARD FROM THE FRONT HAPTIC AND WHICH WAS HAPPENED FOR 4 LENSES. IN THE CASE OF ONE LENS, THE REAR HAPTICS ALSO POPPED OUT ON THE SAME WAY. THE LENS CANNOT BE PLACED SAFELY ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, SURGEON ITSELF PREFILLED THE LENS AND THE FRONT OPTIC DID NOT COME OUT OF THE SLED NORMALLY. POPPING UP EARLY LIKE A CADUCEUS AND COULD NOT BE PLACED ON THE PATIENT AT ALL. ONE OF THE LENSES ALSO HAD THE SAME PROBLEM WITH THE LOWER OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 17106089 ↗
• MalfunctionJun 12, 2023Failure to Eject; Failure to Eject

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT COME OUT OF THE CARRIAGE IN THE NORMAL WAY, BUT POPPED OUT LIKE A DRAIN OUT AND FORWARD FROM THE FRONT HAPTIC AND WHICH WAS HAPPENED FOR 4 LENSES. IN THE CASE OF ONE LENS, THE REAR HAPTICS ALSO POPPED OUT ON THE SAME WAY. THE LENS CANNOT BE PLACED SAFELY ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, SURGEON ITSELF PREFILLED THE LENS AND THE FRONT OPTIC DID NOT COME OUT OF THE SLED NORMALLY. POPPING UP EARLY LIKE A CADUCEUS AND COULD NOT BE PLACED ON THE PATIENT AT ALL. ONE OF THE LENSES ALSO HAD THE SAME PROBLEM WITH THE LOWER OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 17106087 ↗
• MalfunctionJun 6, 2023Failure to Eject; Failure to Eject

  AN INVENTORY COORDINATOR REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PLUNGER WOULD NOT ENGAGE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NO INFORMATION WAS PROVIDED RELATED TO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 17074258 ↗
• MalfunctionJun 1, 2023Failure to Advance; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING THE PROCEDURE, LENS BECAME LODGED IN THE INJECTOR / INTRODUCER AND WAS UNABLE TO BE USED AND IMPLANTED. THE LENS WAS DISCARDED AND NEW LENS AND INTRODUCER OBTAINED AND USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17038286 ↗
• MalfunctionAug 22, 2022Failure to Deliver; Failure to Deliver

  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 15265193 ↗
• InjuryAug 5, 2022Failure to Eject; Physical Resistance/Sticking; Failure to Eject; Physical Resistance/Sticking

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PUSHING THE BLUE PLUNGER, A RESISTANCE OCCURRED THAT CAUSED A JOLT, AND THE IMPLANT CAME OUT ABRUPTLY AND CAUSED AN IMMEDIATE CAPSULE RUPTURE, A 3-PIECE IMPLANT WAS SUBSEQUENTLY DESTERILIZED BUT ULTIMATELY NOT PLACED. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2022. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15176672 ↗
• InjuryJul 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PURCHASING MANAGER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE LENS WAS DISLOCATED 3 DAYS AFTER THE INITIAL PROCEDURE OF VITRECTOMY. THE IOL WAS REPLACED WITH A SULCUS LENS AS THE CAPSULE WAS NOT INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 14906488 ↗
• MalfunctionMay 24, 2022Defective Component; Defective Component

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE INJECTOR HAD FAILED. THE TIP WAS IN CONTACT WITH THE PATIENT. THE SURGERY WAS COMPLETED WITH A BACK UP LENS IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14488617 ↗
• MalfunctionMar 16, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A SCRUB TECHNICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION WHEN THE DOCTOR WENT TO INJECT THE LENS NOTHING CAME OUT. THE DELIVERY SYSTEM NOT WORK PROPERLY AS THE PLUNGER ORIGINALLY BYPASSED THE LENS AND NOTHING CAME OUT CAUSING THE LENS TO BE CRUSHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND WAS NOT HOSPITALIZED FOR THE EVENT. NO SURGICAL OR MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13786932 ↗
• MalfunctionDec 21, 2021Crack; Crack

  A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS BEING CRACKED UPON INSERTION INTO THE EYE. THE PROCEDURE WAS COMPLETED WITH THE ALTERNATIVE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13055535 ↗
• MalfunctionDec 14, 2021Defective Device; Defective Device

  A HEALTH PROFESSIONAL REPORTED THAT THE PLUNGER WAS LOOSE AND DID NOT WORK, SO THE LENS DID NOT COME OUT. THERE WAS A PATIENT CONTACT REPORTED AND WITH NO PATIENT HARM. THERE WAS A ONE MINUTE DELAY DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12999022 ↗