AcrySof® UltraSert® AU00T0 (UDI 00380652394710)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
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652394710), received between Mar 8, 2021 and Feb 17, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (3 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 Advance3
- Defective Component2
- Defective Device2
- Device Damaged by Another Device2
- Device Difficult to Setup or Prepare2
- Failure to Unfold or Unwrap2
- Failure to Deliver1
- Failure to Eject1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION THAT THE INJECTOR MISGUIDED DURING INSERTION.
Patient problems: Insufficient Information
MAUDE report 24364264 ↗MalfunctionJul 31, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED THAT LENS STUCK IN CARTRIDGE AND COULD NOT INSERT IOL. THERE WAS PATIENT CONTACT WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676191 ↗MalfunctionMay 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS TRAILING HAPTIC FOLDED WRONG, FEET CAME FIRST, DID NOT COME OUT OF SHOOTER. HENCE THE LENS WAS TAKEN FROM THE INJECTOR AND PUT IN ANOTHER SHOOTER AND WAS IMPLANTED. THERE ARE EIGHT MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 7 OF 8. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT IN THE SURGEON OPINION, INCORRECT POSITION OF THE LENS IN THE CARTRIDGE CAUSED THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21959727 ↗MalfunctionFeb 18, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NURSE CALLED TO REPORT AN ISSUE. WHILE IMPLANTING THE LENS USING THE COMPANY INJECTOR, THE PLUNGER SUDDENLY BROKE, THE LENS THAT WAS IMPLANTED INSIDE THE BAG AND THE HAPTIC WAS CUT OFF. LENS WAS INSIDE THE PATIENT'S EYE A REPLACEMENT LENS IS REQUESTED TO FACILITATE EXPLANTATION AND INVESTIGATION, WITH THE PROCEDURE TO BE SCHEDULED UPON RECEIPT OF THE REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21394130 ↗MalfunctionSep 5, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER MISSED THE LENS, UNABLE TO IMPLANT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146571 ↗MalfunctionApr 16, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19114604 ↗MalfunctionMar 21, 2024Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949896 ↗MalfunctionJan 9, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT/ VITRECTOMY COMBINATION PROCEDURE, INTRAOCULAR LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18481126 ↗MalfunctionNov 6, 2023Failure to Advance; Failure to Advance
AN OPHTHALMOLOGIST REPORTED THAT DURING SURGERY, THE PRE-FILLED LENS INJECTION PROCESS FAILED; THE PLUNGER DID NOT DRAG THE LENS INTO THE NOZZLE. THE SURGERY WAS COMPLETED USING ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 18074551 ↗MalfunctionOct 26, 2023Defective Component; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INJECTOR MISMATCHED AT SYRINGE LEVEL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18010600 ↗MalfunctionJul 28, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHARMACIST REPORTED REGARDING AN INTRAOCULAR LENS WHICH DID NOT OPEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15119350 ↗MalfunctionJun 8, 2022Device Damaged by Another Device; Device Damaged by Another Device
A DOCTOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS TORN. THE IOL WAS REPLACED WITH BACK-UP LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14635222 ↗MalfunctionMay 26, 2022Defective Component; Defective Component
A PURCHASING AGENT REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEFECTIVE PLUNGER WAS NOTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THERE WAS A PATIENT CONTACT AND THE PATIENT WAS NOT HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14507027 ↗MalfunctionJul 15, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC OF THE IOL CAME STRAIGHT OUT AND THE IOL FOLDED OVER ITSELF. THERE WAS CONTACT BETWEEN THE PATIENT AND THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172675 ↗MalfunctionMar 8, 2021Inaccurate Delivery; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS A LOADING ERROR WHEN INSERTING INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11435821 ↗
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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