AcrySof® UltraSert® AU00T0 (UDI 00380652394901)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

All models of AcrySof UltraSert (102)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652394901), received between Oct 3, 2022 and Jul 28, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Appropriate Device Problem Term/Code Not Available2
Device Damaged by Another Device2
Failure to Advance2
Failure to Eject2
Crack1
Device Difficult to Setup or Prepare1
Product Quality Problem1
Scratched Material1

Patient problems

Insufficient Information7
No Clinical Signs, Symptoms or Conditions2
Corneal Edema1
Eye Injury1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 28, 2026Failure to Advance; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048731 ↗
MalfunctionDec 24, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SCRATCHES OR BLEMISHES¿SUCH AS INDENTATIONS, SCUFF MARKS, OR SCORE MARKS¿WERE OBSERVED ON THE OPTIC AFTER THE LENS WAS IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23887773 ↗
MalfunctionDec 15, 2025Product Quality Problem; Product Quality Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING NO SECOND PROCEDURE WAS NECESSARY. THE BACKUP LENS WAS INSERTED DIRECTLY DURING THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23809862 ↗
MalfunctionFeb 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT, WHEN INSERTING THE LENS, THE HAPTICS GET CAUGHT IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21332175 ↗
InjuryAug 6, 2024Failure to Advance; Failure to Advance
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH AN UNSPECIFIED IOL IN A SECONDARY PROCEDURE. THE PATIENT¿S CONDITION WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919215 ↗
MalfunctionDec 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT WITH VITRECTOMY PROCEDURE, IT WAS NOTED THAT THE LENS FAILED TO LOAD DURING IMPLANTATION. AS THE CAPSULE WAS BURST, THE SURGEON PROCEEDED FOR VITRECTOMY AND ENDED UP USING MULTIPIECE COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18415487 ↗
MalfunctionDec 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT WITH VITRECTOMY PROCEDURE, IT WAS NOTED THAT THE LENS FAILED TO LOAD DURING IMPLANTATION. AS THE CAPSULE WAS BURST, THE SURGEON PROCEEDED FOR VITRECTOMY AND ENDED UP USING MULTIPIECE COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18408664 ↗
MalfunctionAug 14, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS IMPLANTED IN THE PATIENT, THE POSTERIOR HAPTIC GOT CAUGHT IN THE PLUNGER AND THE LENS BROKE. FOR THE MOMENT, THE LENS HAS NOT BEEN EXPLANTED AND HAS NOT BEEN REPLACED BY ANOTHER ONE, AS THE PATIENT HAD INFLAMMATION DUE TO OTHER PATHOLOGIES IN ADDITION TO THE SURGERY, WHICH HAD BEEN COMPLICATED.
Patient problems: Insufficient Information
MAUDE report 17541037 ↗
MalfunctionJun 30, 2023Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE LENS INJECTED INTO THE PATIENT EYE AND THERE WAS A CRACK NEXT TO THE HAPTIC OF THE LENS. IT WAS DECIDED TO LEAVE THE LENS IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17237958 ↗
InjuryOct 3, 2022Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PLUNGER WENT THROUGH THE LENS AND VISCOELASTIC WAS USED TO LOAD THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED WHICH SATES THAT CORNEAL WOUND WAS ENLARGED TO TAKE OUT THE LENS IN THE INITIAL PROCEDURE. POST SURGERY THE PATIENT EXPERIENCED TEMPORARY CORNEAL EDEMA. THE PATIENT WAS NOT HOSPITALIZED AND THE SYMPTOMS WAS RESOLVED.
Patient problems: Corneal Edema; Eye Injury
MAUDE report 15528745 ↗

Device details

UDI-DI	`00380652394901`
Brand	AcrySof® UltraSert®
Model	AU00T0
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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