AcrySof® UltraSert® AU00T0 (UDI 00380652394833)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Single-Piece Posterior Chamber Lenses with the UltraSert® Pre-loaded Delivery System · Class 3 · Implant
Quick summary
This Alcon AcrySof UltraSert AU00T0 is a foldable artificial lens used during cataract surgery, preloaded in a delivery system. The 28 reports mostly describe the lens or injector misbehaving during surgery: haptics or lens parts breaking inside the injector, the lens not advancing or failing to eject, marks or scratches on the lens, and the delivery system damaging the lens before it could be loaded. Some surgeries needed a different lens. 3 reports mention injuries and there are no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380652394833), received between Mar 12, 2021 and Sep 25, 2026 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (6 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.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device6
- Failure to Advance5
- Break4
- Failure to Deliver3
- Failure to Eject3
- Scratched Material3
- Defective Component2
- Device Difficult to Setup or Prepare2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information14
- Capsular Bag Tear2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Damaged by Another Device
A non-healthcare professional reported that, before the intraocular lens implantation surgery, one of the haptics was found to be broken. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895641 ↗MalfunctionSep 25, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon stated loop was twisted. The procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50894914 ↗MalfunctionAug 10, 2026Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191725 ↗MalfunctionApr 24, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE PRESSED THE PISTON FOR TOO MUCH SO THAT IT DOES NOT TAKE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 4.
Patient problems: Insufficient Information
MAUDE report 24981440 ↗MalfunctionMar 18, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, ONCE THE LENS WAS INSERTED IT WAS NOTED THERE WAS MARK ON THE LENS. SURGEON TRIED TO MOVE THE LENS SO THAT THE MARK WILL NOT AFFECT THE PATIENT VISION TOO MUCH AND THE MARK WAS LOCATED ON THE SIDE OF THE LENS. ADDITIONAL INFORMATION RECIEVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED BECAUSE OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 24632236 ↗MalfunctionMar 12, 2026Failure to Advance; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PLUNGER PASSED OVER THE LENS AND SCRATCHED IT, PREVENTING THE LENS FROM BEING LOADED. THERE WAS NO PATIENT CONTACT 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 24579329 ↗MalfunctionFeb 13, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC FAULT. THE DEVICE DIDN'T COME IN CONTACT WITH PATIENT 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 24333374 ↗MalfunctionJan 14, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAILURE TO ADVANCE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY USING OTHER SIMILAR TYPE COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 24068794 ↗MalfunctionNov 18, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS STUCK IN DELIVERY SYSTEM OR LENS DID NOT GO THROUGH THE SHUTTER AND SO SURGEON HAD TO IMPLANT ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS PATIENT CONTACT, AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 23580386 ↗MalfunctionNov 12, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYISICIAN REPORTED THAT DURING PHAKIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536047 ↗MalfunctionJun 23, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL HAD REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, ONE OF THE LENS HAPTICS BECAME STUCK IN THE INJECTOR PISTON AND BROKE OFF. AS A RESULT, A NEW LENS WAS IMPLANTED SUCCESSFULLY. THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: Insufficient Information
MAUDE report 22305948 ↗MalfunctionJun 11, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INSERTION OF THE IOL INTO POSTERIOR BAG, NOTED HAPTIC WAS BROKEN WHEN THE LENS OPENED IN THE BAG. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER MODEL 0.5 DIOPTER MORE SAME COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22185701 ↗MalfunctionApr 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21899236 ↗MalfunctionApr 17, 2025Break; Failure to Deliver; Failure to Advance; Break; Failure to Deliver; Failure to Advance
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PLUNGER OVER-RIDE WAS NOTICED. THERE WAS PATIENT CONTACT. PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854217 ↗MalfunctionFeb 13, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT A SMALL SCRATCH WAS OBSERVED IN THE PERIPHERY OF THE LENS. THE LOCATION OF THE SCRATCH WOULD NOT AFFECT THE PATIENT VISION, SO THE SURGEON DECIDED TO KEEP THE LENS. THE LENS REMAINS IMPLANTED IN PATIENTS EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21376548 ↗MalfunctionJan 13, 2025Defective Component; Failure to Eject; Defective Component; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE PREPARING THE IOL FOR IMPLANTATION, VISCOELASTIC WAS INTRODUCED. THE PLUNGER PASSED OVER THE IOL AND PINCHED THE POSTERIOR HAPTIC AT THE EXIT. THERE WAS NO CONTACT BETWEEN THE PATIENT AND THE IOL AND NO PATIENT HARM. THE LENS WAS REPLACED WITH AN IDENTICAL ONE AND COMPLETED THE PROCEDURE ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137507 ↗MalfunctionOct 18, 2024Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS( IOL) BROKE IN THE EYE DURING INSERTION. LENS WAS REMOVED AND ANOTHER IOL WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20481623 ↗MalfunctionOct 3, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INJECTOR WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED WHEN LOADING, THE PISTON WENT OVER THE LENS AND FINALLY THE LENS GOT "STUCK" ON THE END OF THE INJECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL.
Patient problems: Insufficient Information
MAUDE report 20359969 ↗MalfunctionMar 8, 2024Failure to Fold; Failure to Fold
A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18866942 ↗InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL IMPLANTED LENS AND FOUND A POSTERIOR CAPSULE RUPTURE. IT WAS NOT STABLE IN THE CAPSULE BAG, DOCTOR DECIDED TO IMPLANT ANOTHER MODEL COMPANY LENS AT THE SULCUS. THE OPERATION COMPLETED ON THE SAME DAY. THE EVENT OCCURRED DURING SURGERY OF CATARACT SURGERY (WITH IOL IMPLANT). THE SURGERY WAS COMPLETED. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 18365379 ↗MalfunctionJun 1, 2023Unintended Ejection; Failure to Eject; Unintended Ejection; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS EJECTED IOL EJECTED IN AN UNCONTROLLED MANNER, DUE TO FAULTY- PRELOADED INJECTOR. THERE WAS NO HARM TO THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17036263 ↗MalfunctionMay 11, 2023Failure to Advance; Failure to Advance
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PART OF THE IMPLANT REMAINS STUCK IN THE INJECTOR, EVEN AFTER INSISTING IT DOES NOT COME OUT COMPLETELY IN THE EYE. THERE WAS NO PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT, WITH THE SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16911055 ↗InjuryOct 17, 2022Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE MOMENT OF IMPLANTATION OF IOL ON THE EYE, A BROKEN LOOP WAS DETECTED, SO IT WAS NECESSARY TO REMOVE THE LENS AND REPLACE IT WITH ANOTHER LENS DURING INITIAL PROCEDURE. ONE STITCH OF SUTURE WAS PLACED ON THE SITE OF IOL. THERE IS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15616107 ↗MalfunctionAug 16, 2022Break; Failure to Eject; Break; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY IT WAS DIFFICULT TO EJECT LENS FROM THE INJECTOR, RESULTING IN A TORN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND THE LENS WAS NOT REMOVED FROM THE EYE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15233884 ↗MalfunctionMar 7, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL DID NOT UNFOLD IN PATIENT'S EYE UPON INSERTION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13677724 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.