AcrySof® UltraSert® AU00T0 (UDI 00380652394604)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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652394604), received between May 6, 2025 and May 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
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 Damaged by Another Device1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PISTON WENT OVER THE LENS DURING PREPARATION, RESULTING IN LENS DAMAGE AND COULD NOT INSERT IT. A SECOND LENS WAS USED TO COMPLETE THE SURGERY. THE ISSUE OCCURRED DURING LENS PREPARATION, AND THERE WAS NO PATIENT CONTACT OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22044639 ↗MalfunctionMay 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS INCORRECTLY LOADED INTO THE SHOOTER, FEET CAME FIRST. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, IN THE SURGEONS OPINION, PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT WAS INCORRECT POSITION OF THE LENS IN THE CARTRIDGE. THERE WAS NO PATIENT IMPAIRMENT. SYMPTOMS WERE RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967046 ↗
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- 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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