AcrySof® UltraSert® AU00T0 (UDI 00380652394772)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 is a foldable lens for cataract surgery, preloaded in an injector cartridge. The 49 reports mostly describe delivery problems during surgery: the injector being hard to set up or damaged by other instruments, the lens failing to eject or advance, and lenses arriving scratched or broken. Eight reports mention patient injury, with no deaths. One recall, closed in April 2020, was for a lens with the wrong focusing power. Reports dropped from 15 in the prior 12 months to 5 in the most recent 12 months.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00380652394772), received between Mar 8, 2021 and Sep 22, 2026 — classified as 8 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (8 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Apr 17, 2020Terminated
Incorrect IOL diopter
Z-2287-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Damaged by Another Device8
- Device Difficult to Setup or Prepare7
- Failure to Eject6
- Inaccurate Delivery6
- Failure to Advance5
- Break4
- Adverse Event Without Identified Device or Use Problem3
- Failure to Deliver3
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information13
- Corneal Edema3
- Visual Impairment2
- Eye Injury1
- Inflammation1
- Zonular Dehiscence1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Twisted/Bent
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, during loading the haptic was found to be bent, crimped, distorted, or twisted and the doctor suspected that it would damage the lens pouch. There was no patient contact.Additional information has been requested, received and stated the issue noticed with leading haptic.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850870 ↗MalfunctionMay 13, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED AFTER IMPLANTATION ARTHRITIC OBSERVED A SCRATCH ON THE MIDDLE OF THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WERE NO REPORTED PATIENT HARM AND PATIENT CONDITION RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162315 ↗MalfunctionJan 28, 2026Inaccurate Delivery
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT IMPLANTED BECAUSE, AT THE TIME OF INJECTION IT DID NOT ENTER THE TUNNEL BUT SLIPPED ON THE CORNEAL SURFACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24198931 ↗MalfunctionJan 16, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THERE WAS ISSUE WITH INJECTOR AND NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095614 ↗MalfunctionNov 12, 2025Break; Break
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS BROKEN. THE PRODUCT WAS NOT APPLIED ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23530739 ↗MalfunctionOct 23, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT THE PISTON WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23368897 ↗MalfunctionOct 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23279748 ↗MalfunctionAug 13, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE ADVANCING PIN DID NOT ENGAGE WITH LENS. NO PATIENT HARM. PROCEDURE COMPLETED WITH THE NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795053 ↗MalfunctionAug 12, 2025Material Deformation; Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS GOT UNSTERILE DURING IMPLANTATION AND THE SURGERY WAS COMPLETED USING AN OTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782445 ↗MalfunctionAug 4, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT, IOL STUCK IN THE CARTRIDGE AND COULD NOT INSERT THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND CUSTOMER DID NOT WISH TO BE CONTACTED.
Patient problems: Insufficient Information
MAUDE report 22700718 ↗MalfunctionJul 25, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FEET (HAPTIC) BROKE OFF AT THE TIME OF INSERTION. THE LENS WAS EXPLANTED DURING THE SAME PROCEDURE AND REPLACED WITH A LENS OF THE SAME MODEL AND DIOPTER FROM THE SAME COMPANY. THE SURGERY WAS COMPLETED ON THE SAME DAY. NO UNSCHEDULED MEDICATION OR UNPLANNED MEDICAL OR SURGICAL PROCEDURE WAS NECESSARY AS A RESULT OF THE EVENT. THE PATIENT WAS NOT HOSPITALIZED. THE SURGEON'S PROGNOSIS WAS UNCHANGED, AS THE SURGERY WAS COMPLETED WITH A REPLACEMENT LENS. IN THE SURGEON'S OPINION, SINCE IT WAS A PRE-LOADED LENS, THE EVENT WAS ASSUMED TO BE CAUSED BY A DEFECT IN THE LENS.
Patient problems: Insufficient Information
MAUDE report 22610151 ↗MalfunctionJul 22, 2025Failure to Advance; Failure to Advance
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SUDDEN LET GO OF PLUNGER GLIDE HAD HAPPENED DURING LENS DELIVERY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564760 ↗MalfunctionJul 2, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STARTED TO COME OUT WITH THE HAPTIC FIRST. THE DOCTOR CORRECTED THE LENS THROUGH THE INCISION. WHEN ATTEMPTING TO INSERT THE LENS, IT GOT STUCK ON THE INJECTOR PLUNGER. IT WAS REMOVED FROM THE EYE AS IT DID NOT DEPLOY. THE SURGERY 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 22380783 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FAULTY, HAPTIC ISSUE. THE SURGERY WAS COMPLETED USING THE BACK UP LENS AND THERE WAS NO PATIENT CONTACT. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345817 ↗MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FAULTY, HAPTIC ISSUE. THE SURGERY WAS COMPLETED USING THE BACK UP LENS AND THERE WAS NO PATIENT CONTACT. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345584 ↗MalfunctionJun 20, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS ABOUT TO BE INJECTED INTO THE EYE, IT WAS NOTICED THAT THE HAPTIC OF THE LENS WAS BROKEN. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299146 ↗MalfunctionMay 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
THERE ARE EIGHT MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 5 OF 8. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21959029 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ZONULYSIS AFTER LENS IMPLANTATION. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED MULTI PIECE LENS.
Patient problems: Zonular Dehiscence
MAUDE report 21719133 ↗MalfunctionMar 4, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING OR PRIMING THE INTRAOCULAR LENS SCRATCHED BY THE INJECTOR. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER LENS ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21513164 ↗MalfunctionJan 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED. THE LENS DID NOT TOUCH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196683 ↗MalfunctionAug 14, 2024Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DAMAGED, THE PLUNGER WAS MOVED TO CORRECTLY SEE THE LENS TRAJECTORY THROUGH THE CARTRIDGE, AT THE TIME OF IMPLANTATION, THE PLUNGER SECTIONED ONE OF THE LENS HAPTICS. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19979618 ↗InjuryJul 8, 2024Break; Device Difficult to Setup or Prepare; Inaccurate Delivery; Difficult to Advance; Break; Device Difficult to Setup or Prepare; Inaccurate Delivery; Difficult to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, DUE TO A DEFECT IN THE INJECTOR, THE IOL'S HAPTIC WAS AMPUTATED AND IT REMAINED BROKEN INSIDE THE INJECTOR. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL. NO INFORMATION RELATED TO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT IS A DOCTOR, HE WAS RECOVERING, BUT HE HAD A LARGE CORNEAL EDEMA AND THERE WAS A NEED FOR REINTERVENTION. DUE TO THE COMPLICATIONS, HIS DAILY ACTIVITIES GOT IMPAIRED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT DURING SURGERY THE HAPTIC OF THE LENS BROKE OFF AND GOT STUCK IN THE SYRINGE, SO IT HAD TO BE REMOVED AND A NEW LENS FITTED, WHICH CAUSED A MUCH LARGER THAN NORMAL INJURY TO THE CORNEA/ CORNEAL EDEMA. THIS LED TO THE NEED FOR A NEW PROCEDURE IN THE OPERATING ROOM ON (B)(6) 2024. APPROXIMATELY AFTER 3 WEEKS, STITCHES WERE REMOVED. HE ADDITIONALLY REPORTED THAT AFTER 15 DAYS' TIME, HE WILL BE BACK FOR FURTHER TESTS TO SEE IF HE HAD ANY RESIDUAL DAMAGE. ADDITIONAL INFORMATION WAS RECEIVED STATED THAT THE IOL WAS IMPLANTED AND EXPLANTED. REINTERVENTI
Patient problems: Corneal Edema; Insufficient Information
MAUDE report 19690938 ↗MalfunctionJun 12, 2024Failure to Advance; Failure to Advance
A NURSE REPORTED THAT A PRELOAD LENS DID NOT IMMERSE IN THE INSERTER. THE SURGERY WAS COMPLETED USING A BACKUP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19518584 ↗MalfunctionApr 22, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING INSERTION OF THE INTRAOCULAR LENS (IOL), DURING AN IMPLANT PROCEDURE, A BIT OF RESISTANCE WAS EXPERIENCED. PLUNGER WAS STILL PUSHED TO IMPLANT THE LENS HOWEVER THE PLUNGER BROKE TOGETHER. THE LENS WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19152252 ↗InjuryApr 12, 2024Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANT THE SURGEON NOTICED THAT YELLOW KIND OF PRECIPITATION WAS THERE ON THE CENTRAL PART OF OPTICS. IMMEDIATELY THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED POST OPERATIVE DAY ONE MICROCYSTIC OEDEMA NOTED, SO WAS GIVEN STEROIDAL ANTI-INFLAMMATORY DRUG ELD, MOXIFLOXACIN ELD, TIMOLOL-P, HOMIDE ELD, AND ORAL STEROID.
Patient problems: Corneal Edema
MAUDE report 19096048 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.