AcrySof® UltraSert® AU00T0 (UDI 00380652394680)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
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652394680), received between Mar 15, 2021 and Dec 19, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (3 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
Most reported problems
Device problems
- Failure to Eject3
- Device Damaged by Another Device2
- Device Difficult to Setup or Prepare2
- Failure to Advance2
- Defective Component1
- Defective Device1
- Failure to Deliver1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT ONE LEG/HAPTIC OF THE IOL (INTRAOCULAR LENS) HAD A DAMAGE. THERE WAS PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS TO BE USED IN A STANDARD CATARACT OPERATION.
Patient problems: Insufficient Information
MAUDE report 23850256 ↗MalfunctionAug 5, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT, DURING CALIBRATION THE HAPTICS WERE IN THE WRONG POSITION AND TORN, SO THE SURGEON WAS UNABLE TO USE THE LENS AND IT WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 22715394 ↗MalfunctionAug 1, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING PREPARATION IT WAS NOTED THAT THE LENS STUCK IN THE CARTRIDGE AND COULD NOT INSERT THE IOL. THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT HARM. OPERATION DELAYED 4 MINUTES DUE TO THE INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688203 ↗MalfunctionJun 2, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED THAT DEFECTIVE DELIVERY CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 22124475 ↗MalfunctionFeb 18, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT DRAG THE LENS CORRECTLY BY PASSING THE PLUNGER OVER IT. ANOTHER LENS WAS TAKEN TO CONTINUE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21400082 ↗MalfunctionJan 28, 2025Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY LENSES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING DURING INJECTING FAULTY, LENS DID NOT COME OUT PROPERLY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21251864 ↗MalfunctionJun 19, 2024Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS HAS GONE CLOUDY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT VISION WAS 6/6, BUT SYMPTOMATIC. NOT EXPLANTED YET.
Patient problems: Insufficient Information
MAUDE report 19567027 ↗MalfunctionFeb 13, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED FAULTY DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18694087 ↗MalfunctionDec 11, 2023Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS ON A ROLLER IN THE SETTER. TAKEN A NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18299859 ↗InjuryNov 24, 2023Defective Component; Defective Component
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT STILL HAS CORECTOPIA BUT HIS OVERALL CONDITION IS VERY GOOD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury
MAUDE report 18204176 ↗MalfunctionSep 20, 2023Failure to Unfold or Unwrap; Failure to Eject; Failure to Unfold or Unwrap; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS FAILED TO DEPLOY PROPERLY AND FAILED TO OPEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17780209 ↗MalfunctionMar 15, 2021Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD THAT A PRELOADED INTRAOCULAR LENS (IOL) DIDN'T ADVANCE INSIDE THE LOADER, CRUMBLED UP AND WAS WASTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11484235 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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