AcrySof® UltraSert® ACU0T0 (REF ACU0T0.285)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 00380652395427), received between Feb 18, 2022 and May 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 Advance2
- Defective Device1
- Inaccurate Delivery1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WHEN THE SURGEON WAS INTRODUCING SHOT OUT THE END OF THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LENS WAS PRIMED USING COMPANY OPHTHALMIC VISCOSURGICAL DEVICE AND SURGEON TRIED TO ENGAGE THE INJECTOR WITH CARTRIDGE THE LENS SHOT OFF. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086962 ↗MalfunctionMar 5, 2024Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHILE LOADING THE LENS STUCK IN INJECTOR WHICH DIDN¿T FULLY EJECT INTO THE EYE. THE SURGERY WAS COMPLETED WITH NEW LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18835628 ↗MalfunctionDec 12, 2022Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION IT WAS NOTICED THAT THE LENS WAS FAILED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND WAS FURTHER CLARIFIED THAT THE LENS FAILED TO INJECT. THERE WAS PATIENT CONTACT BUT NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING A BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15957158 ↗MalfunctionFeb 18, 2022Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13559741 ↗
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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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