AcrySof® UltraSert® AU00T0 (UDI 00380652394895)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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652394895), received between Dec 10, 2021 and Sep 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
Most reported problems
Device problems
- Device Difficult to Setup or Prepare2
- Failure to Fold1
- Failure to Unfold or Unwrap1
- Scratched Material1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A Facility representative reported that during Intraocular lens (IOL) implantation lens did not load into injector.Additional information has been requested, yet no new information received.
Patient problems: Insufficient Information
MAUDE report 50899132 ↗MalfunctionJul 8, 2025Scratched Material; Scratched Material
A NURSE REPORTED WITH A DESCRIPTION OF DAMAGED LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS WAS INSERTED AND WHEN THE LENS WAS IN PLACE, IT WAS NOTICED THAT THE LENS WAS SCRATCHED. LENS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22436966 ↗MalfunctionJun 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS LEADING HAPTIC CAME OUT FROM THE INJECTOR TOO EARLY. SURGEON WANTED TO BE SURE THAT INJECTING WILL GO SMOOTHLY SO THEY TOOK NEW UNSPECIFIED ONE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 5 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168825 ↗MalfunctionDec 10, 2021Failure to Fold; Failure to Unfold or Unwrap; Failure to Fold; Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL FOLDS DOUBLE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12977197 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page