AcrySof® UltraSert® ACU0T0 (REF ACU0T0.275)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652395403), received between Dec 29, 2021 and Aug 6, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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
- Failure to Unfold or Unwrap2
- Defective Device1
- Device Damaged by Another Device1
- Failure to Advance1
- Failure to Deliver1
- Failure to Eject1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS POSITIONED FORWARD AND WAS COMPLETELY TWISTED, AFFECTING THE ANTERIOR HAPTIC. THE LENS DID NOT COME INTO CONTACT WITH THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726653 ↗MalfunctionJul 16, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME STUCK INSIDE THE CARTRIDGES DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22521552 ↗MalfunctionFeb 2, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.
Patient problems: Insufficient Information
MAUDE report 18630712 ↗MalfunctionAug 31, 2023Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT INTRAOCULAR LENS (IOL) DAMAGED IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17660448 ↗MalfunctionDec 29, 2021Failure to Unfold or Unwrap; Failure to Eject; Failure to Unfold or Unwrap; Failure to Eject
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS DID NOT UNFOLD AND WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13109756 ↗MalfunctionDec 29, 2021Failure to Unfold or Unwrap; Failure to Advance; Failure to Unfold or Unwrap; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD AND WOULD NOT ADVANCE. PATIENT CONTACT WAS NOTED, AND PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13109321 ↗
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.
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