AcrySof® UltraSert® AU00T0 (UDI 00380652394758)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 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is a pre-loaded lens used in cataract surgery. The 40 reports mostly describe problems with the injector, such as difficulty loading or priming it, the lens sticking or failing to advance or eject, and occasional damage to the lens or its supports. There are no deaths, 4 injuries and 36 malfunctions, and no recalls name this device. Reports of these problems have been steady over the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00380652394758), received between Apr 16, 2021 and Sep 26, 2026 — classified as 4 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare9
- Failure to Eject8
- Device Damaged by Another Device5
- Failure to Deliver5
- Failure to Advance4
- Defective Component3
- Defective Device3
- Scratched Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information19
- Eye Injury1
- Eye Pain1
- Retinal Tear1
- Viral Infection1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50906911 ↗MalfunctionJul 15, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 25825447 ↗MalfunctionJul 15, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 25825446 ↗MalfunctionMar 23, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGERY HAS BEEN COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24664040 ↗MalfunctionMar 9, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CATARACT SURGERY INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION, A FRACTURE OF THE HAPTIC WAS IDENTIFIED. THE SURGEON USED ANOTHER LENS AND SUCCESSFULLY COMPLETED THE SURGERY. THERE WAS NO PATIENT CONTACT WITH THE ORIGINAL DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544282 ↗MalfunctionDec 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IOL GOT RESISTANCE WHILE INSERTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23876719 ↗MalfunctionDec 17, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH MARK ON THE LENS AFTER IMPLANTATION. THE LENS WAS LEFT IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827178 ↗MalfunctionDec 12, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME STUCK IN THE INJECTOR. THERE WAS NO PATIENT HARM, AND THE SURGERY WAS SUCCESSFULLY COMPLETED USING A BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23787240 ↗MalfunctionDec 5, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UNABLE TO INJECT THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23727228 ↗MalfunctionDec 2, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS FAILED TO ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23701009 ↗MalfunctionOct 27, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE INJECTOR. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 23391060 ↗MalfunctionJul 21, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER PASSED UNDER THE LENS. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS COMPLETED WITH THE COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553661 ↗MalfunctionJul 7, 2025Device Damaged by Another Device; Device Damaged by Another Device
ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS LOADED WITH NON-COMPANY VISCOELASTIC AND WHEN LOADING THE LENS, HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412077 ↗MalfunctionMay 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE TRAILING HAPTIC FOLDED WRONG, WRONG LOADED IN SHOOTER, FEET FIRST. HENCE THE LENS WAS TAKEN FROM THE INJECTOR AND PUT IN ANOTHER SHOOTER AND WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT IN THE SURGEON OPINION, INCORRECT POSITION OF THE LENS IN THE CARTRIDGE CAUSED THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21970569 ↗MalfunctionMay 2, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS ON THESE LENS ARE COMPLETELY STRAIGHT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21951842 ↗MalfunctionMar 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC DAMAGED OR JAMMED IN DELIVERY SYSTEM. THE DOCTOR HAD A HARD TIME WHILE ADVANCING THE PLUNGER DURING IOL LOADING. AS THEY LOOKED IT UP AT MICROSCOPE THE LENS WAS ALREADY STUCK. AS THEY HAD ANOTHER IOL AS BACKUP. SO REPLACED WITH BACKUP IOL WITH SAME POWER. SURGERY WAS COMPLETED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675089 ↗MalfunctionJan 28, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INJECTING OBSERVED TWISTED LEADING HAPTIC. PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252023 ↗MalfunctionJan 28, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS OVERSHOOT AND THERE WAS A POSSIBLE SCRATCH. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 7 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21250672 ↗MalfunctionDec 31, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE PREPARATION DOCTOR FOUND THE TRAILING HAPTIC WAS BROKE BEFORE IMPLANT. DOCTOR DECIDED TO WAIT FOR THE LENS REPLACEMENT THEN RESCHEDULE FOR THE LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY, THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046705 ↗InjuryNov 22, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20758814 ↗MalfunctionOct 23, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION STATING DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20517590 ↗MalfunctionOct 18, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY HAVE NOTICED THAT THE LENS WAS NOT IN THE GOOD CONDITION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS WITH SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20481368 ↗MalfunctionSep 13, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL ADVANCED WITH THE WRONG ORIENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210142 ↗MalfunctionJun 11, 2024Failure to Fold; Failure to Fold
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS DEFECTIVE AND WOULD NOT FOLD CORRECTLY
Patient problems: Insufficient Information
MAUDE report 19509336 ↗MalfunctionJun 3, 2024Failure to Advance; Failure to Advance
A PHARMACY EMPLOYEE REPORTED THAT THE IMPLANT WAS DEFECTIVE, IT DID NOT DEPLOY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19447815 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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