AcrySof® UltraSert® AU00T0 (UDI 00380652394635)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 00380652394635), received between Aug 31, 2022 and Feb 26, 2025 — classified as 6 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
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
- Difficult to Advance1
- Failure to Advance1
- Failure to Eject1
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.
MalfunctionFeb 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAULTY HAD ISSUE WITH THE LEADING HAPTIC WAS NOTICED. THE LEFT EYE WAS AFFECTED. THE PROCEDURE WAS COMPLETED ON SAME DAY AND THE ISSUE HAD CAUSED A 5-MINUTE DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21468177 ↗MalfunctionJul 12, 2024Device Difficult to Setup or Prepare; Device Dislodged or Dislocated; Device Difficult to Setup or Prepare; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS INVERTED WHEN RELOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19728712 ↗MalfunctionNov 15, 2023Failure to Advance; Failure to Advance
A THEATRE PRACTITIONER REPORTED THAT A LENS WAS STUCK ON THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED. THE SURGERY WAS COMPLETED USING ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18138947 ↗MalfunctionApr 20, 2023Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PERIPHERALLY PART OF THE OPTIC EDGE WAS SHAVED OFF AND COULD NOT BE ASPIRATED WITH IRRIGATION AND ASPIRATION. IT DIDN'T FULLY COME OFF AND WAS HINGED AT THE END OF THE LENS. IT WAS RETAINED INSIDE THE EYE AND WAS NOT VISUALLY SIGNIFICANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND SLIVER OF THE LENS GOT SHAVED OFF WHILE BEING INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16774175 ↗MalfunctionSep 30, 2022Difficult to Advance; Failure to Eject; Difficult to Advance; Failure to Eject
AN OTHER HEALTH PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, LENS DID NOT ADVANCE, THE PUSHER WAS GLIDING OVER THE LENS. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH A BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15519071 ↗MalfunctionAug 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE BROKEN PIECE OF PLASTIC WAS FOUND ON TOP OF TRAILING HAPTIC. WHEN ATTEMPT WAS MADE TO SALVAGE THE LENS, IT SHRIVELED UP AND WAS UNSALVAGEABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15326150 ↗
Other intraocular lens devices
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- 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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