AcrySof® UltraSert® AU00T0 (UDI 00380652394796)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is a foldable implant lens used in cataract surgery, delivered through a preloaded injector. The 70 reports mostly describe loading and delivery problems — the lens failing to eject or advance, the cartridge sticking or leaving a haptic behind, the lens or its arms twisted, bent or snapped, and damage from other instruments. Five reports involve injuries; no deaths are described. There are no recalls naming this device.
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
- 74
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00380652394796), received between Mar 19, 2021 and Sep 29, 2026 — classified as 5 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Eject16
- Material Twisted/Bent11
- Device Damaged by Another Device10
- Device Difficult to Setup or Prepare10
- Failure to Advance9
- Defective Device8
- Break6
- Scratched Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Insufficient Information30
- Blurred Vision1
- Capsular Bag Tear1
- Eye Injury1
- Failure of Implant1
- Visual Impairment1
- Vitreous Detachment1
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Discolored
A healthcare professional reported that, following intraocular lens (IOL) implantation surgery, a diffuse coating was observed on the anterior surface of the patient's IOL; however, it was not considered visually significant. Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50934274 ↗MalfunctionSep 24, 2026Device Damaged by Another Device
A nurse reported that during the surgery, the trailing haptic remained behind the plunger. There was no patient contact. Hence the surgeon requested a replacement lens to complete the surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884733 ↗MalfunctionSep 24, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, surgeon stated loop was twisted. The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50884529 ↗MalfunctionSep 21, 2026Material Twisted/Bent
An Other health care professional reported that during intraocular lens (IOL) implantation surgery, upon advancing the plunger, the IOL haptics were observed to be twisted.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50840836 ↗MalfunctionAug 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252018 ↗MalfunctionApr 23, 2026Break; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INSERTION IT WAS NOTICED THAT THE HAPTIC BECAME STUCK & BROKE ON RELEASE. THE PROCEDURE WAS COMPLETED BY HAPTIC RELEASED WITH STRAIGHT TYING FORCEPS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965125 ↗MalfunctionApr 21, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC REMAINED STUCK INSIDE THE CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO CONSEQUENCES TO THE PATIENT. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED USING AN UNSPECIFIED REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939910 ↗MalfunctionMar 6, 2026Device Damaged by Another Device; Material Twisted/Bent
A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON FOUND TO HAVE IOL WAS TWISTED INSIDE THE PRELOAD INJECTOR, PREVENTING IT FROM BEING ADVANCED. THE IOL DID NOT COME INTO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531417 ↗MalfunctionFeb 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A FAULTY HAPTIC WAS OBSERVED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322085 ↗MalfunctionFeb 6, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY THE LENS WAS STUCK IN CARTRIDGE DURING LOADING PROCESS WITH NO PATIENT CONTACT. SURGEON DID NOT USE BECAUSE IT MAY HAVE BEEN SCRATCHED AND SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278955 ↗MalfunctionJan 14, 2026Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LENS WAS IN THE PATIENT'S EYE, SURGEON NOTICED THAT ONE OF THE HAPTICS WAS FRACTURED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. THERE ARE NO FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24068377 ↗MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent
A HEATH PROFESSIONAL REPORTED THAT, A SMALL DENT WHERE THE ARM MEETS THE OPTIC THIS MORNING AFTER A LENS IMPLANT. THE LENS REMAIN IMPLANTED. PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23894553 ↗MalfunctionDec 9, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AFTER IMPLANTATION OF THE LENS, A CHANGE IN THE OPTICS WAS DETECTED AT THE TRANSITION FROM THE OPTICS TO THE HAPTICS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE, AND THE PATIENT WAS FITTED WITH A NEW LENS. THE PATIENT HAD NO RECOGNIZABLE IMPAIRMENT AFTER THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23757063 ↗MalfunctionNov 19, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY WHEN LENS BEING LOADED SURGEON NOTICED THAT THE HAPTIC WAS BROKEN IN THE DELIVERY SYSTEM. SURGERY WAS COMPLETED ON THE SAME DAY.THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595219 ↗MalfunctionAug 8, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO PRE-LOAD DEVICES WERE USED. WITH EACH DEVICE, THE PISTON CONSISTENTLY PUSHED PAST THE IOL ON THE RIGHT SIDE, CAUSING BOTH IOLS TO BE SQUEEZED. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, CONFIRMING THAT BOTH DEVICES WERE USED DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747243 ↗MalfunctionAug 8, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO PRE-LOAD DEVICES WERE USED. WITH EACH DEVICE, THE PISTON CONSISTENTLY PUSHED PAST THE IOL ON THE RIGHT SIDE, CAUSING BOTH IOLS TO BE SQUEEZED. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, CONFIRMING THAT BOTH DEVICES WERE USED DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747240 ↗MalfunctionAug 6, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Material Twisted/Bent; Device Difficult to Setup or Prepare; Failure to Deliver; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IT WAS A STRAIGHT LEADING HAPTIC. THERE WAS PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726994 ↗MalfunctionAug 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FRONT HAPTIC WAS NOT LOADING PROPERLY. THE SURGERY WAS COMPLETED USING AN UNSPECIFIED REPLACEMENT LENS. THERE WAS PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716932 ↗MalfunctionJul 31, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS(IOL) STUCK IN THE CARTRIDGE AND COULD NOT INSERT THE IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22676600 ↗MalfunctionJul 29, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC BROKEN DURING DELIVERY. THIS IS INFECTIOUS CASE, THUS NO SAMPLE AVAILABLE FOR RETURN. PATIENT IMPACT AND PROCEDURE DETAILS WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645831 ↗MalfunctionJul 11, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE PLUNGER COULD NOT BE PUSHED ALL THE WAY DOWN AND THE LENS COULD NOT BE RELEASED. THEREFORE, THE LENS WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22478918 ↗MalfunctionJul 7, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS ABOUT TO BE INJECTED INTO THE EYE, IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS BROKEN. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414561 ↗MalfunctionMay 26, 2025Break; Break
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BROKEN DURING PLACEMENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084803 ↗MalfunctionMay 5, 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 AND RECEIVED STATING IN THE SURGEON OPINION, INCORRECT POSITION OF THE LENS IN THE CARTRIDGE WAS CAUSE OF THE EVENT. THERE WAS NO IMPAIRMENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960538 ↗MalfunctionMay 5, 2025Device Difficult to Setup or Prepare; Failure to Advance; Malposition of Device; Device Difficult to Setup or Prepare; Failure to Advance; Malposition of Device
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 UNSPECIFIED 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. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21959804 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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