AcrySof® UltraSert® ACU0T0 (REF ACU0T0.135)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 00380652395120), received between Jun 15, 2022 and Sep 19, 2025 — classified as 6 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
- Device Damaged by Another Device1
- Device Difficult to Setup or Prepare1
- Failure to Eject1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHILE LOADING, THE LENS WAS TWISTED OR SQUASHED ON THE RIGHT SIDE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095166 ↗MalfunctionAug 11, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS TRAPPED UNDER THE PLUNGER AND THEREFORE NOT COMING OUT OF THE INJECTOR. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22773253 ↗MalfunctionMar 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH A DESCRIPTION OF TRAILING HAPTIC FAULTY AS NOT POSITIONED CORRECTLY ON INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21678001 ↗MalfunctionAug 27, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED FOUR DEFECTIVE PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20073987 ↗MalfunctionApr 15, 2024Failure to Advance; Failure to Advance
A SERVICE MANAGER REPORTED ABOUT A COMPLAINT OF LENS STUCK IN THE INJECTOR. THERE WAS NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH A NEW LENS. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19105410 ↗MalfunctionJun 15, 2022Failure to Eject; Failure to Eject
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE IOL. THERE WAS A CONTACT WITH THE PATIENT BUT NO PATIENT HARM INVOLVED. THE SURGERY WAS DELAYED FOR A MINUTE. THE SURGERY WAS COMPLETED BY USING A BACK-UP LENS AND WITHOUT ANY OTHER PROBLEM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14696666 ↗
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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