AcrySof® UltraSert® AU00T0 (UDI 00380652394581)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652394581), received between Jul 20, 2023 and Nov 27, 2025 — classified as 3 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
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE TRAILING HAPTIC CAME OFF INSIDE THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGERY WAS COMPLETED USING BACKUP LENS WITHOUT ANY HARM TO THE PATIENT THERE WAS NO PATIENT CONTACT, THE ISSUE WAS NOTICED DURING LOADING THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665590 ↗MalfunctionJul 20, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A REPORT WAS RECEIVED FROM THE HEALTH AUTHORITY STATING DURING THE INTRAOCULAR LENS IMPLANTATION THE SURGEON WAS NOT ABLE TO INSERT THE LENS INTO THE EYE DUE TO THE UNFOLDING ISSUES. AS A RESULT THREE LENSES HAD TO BE OPENED BECAUSE THE FIRST TWO LENSES HAD THE SAME ISSUE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17358959 ↗MalfunctionJul 20, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A REPORT WAS RECEIVED FROM THE HEALTH AUTHORITY STATING DURING THE INTRAOCULAR LENS IMPLANTATION THE SURGEON WAS NOT ABLE TO INSERT THE LENS INTO THE EYE DUE TO THE UNFOLDING ISSUES. AS A RESULT THREE LENSES HAD TO BE OPENED BECAUSE THE FIRST TWO LENSES HAD THE SAME ISSUE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17358958 ↗
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- 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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