AcrySof® UltraSert® AU00T0 (UDI 00380652394802)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
Quick summary
This Alcon AcrySof UltraSert AU00T0 is a foldable artificial lens implanted in the eye during cataract surgery, delivered through a pre-loaded injector. The 62 reports mostly describe delivery problems in the operating room: the lens sticking in the injector, failing to advance or release, or bending and breaking, often with the surgery completed the same day using a backup lens. There are no deaths and 2 injuries. No recalls name this device. Reports have dropped from 21 in the prior 12 months to 6 in the last 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
- 65
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00380652394802), received between Apr 12, 2021 and Sep 28, 2026 — classified as 2 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (18 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
- Device Damaged by Another Device18
- Failure to Eject15
- Failure to Advance11
- Material Twisted/Bent8
- Break5
- Defective Device5
- Crack3
- Device Difficult to Setup or Prepare3
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Capsular Bag Tear1
- Eye Injury1
- Eye Pain1
- Intraocular Pressure Increased1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, twisted loop. There was no patient contact. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915641 ↗MalfunctionSep 24, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implantation procedure, twisted loop. There was no patient contact. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884059 ↗MalfunctionSep 17, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device
A healthcare professional reported that during the intraocular lens (IOL) implant procedure, The trailing haptic of the lens was missing when the lens was loaded into capsular bag. The surgeon reported that resistance/friction was encountered with the plunger during delivery of the IOL. The surgeon explanted the damaged IOL and implanted a new IOL to complete the procedure.
Patient problems: Insufficient Information
MAUDE report 50799742 ↗MalfunctionApr 30, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION WHILE THE LENS WAS HALFWAY INSERTED INTO THE EYE, THE HAPTIC WAS FOUND TO BE BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 25045733 ↗MalfunctionJan 30, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) FAILED TO ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE INJECTOR FAIL TO ENGAGE THE LENS. THE SURGEON USED A LIKE-FOR-LIKE LENS AND COMPLETED SURGERY.
Patient problems: Insufficient Information
MAUDE report 24222176 ↗MalfunctionJan 13, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NEEDLE WENT THROUGH THE LENS, DAMAGING THE LENS AND THE POSTERIOR HAPTIC. LENS DID NOT COME IN CONTACT WITH THE PATIENT. A NEW LENS WAS OPENED AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052726 ↗MalfunctionJan 2, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL STUCK IN THE INJECTOR. THE SURGERY COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH SAME COMPANY SAME MODEL LENS. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943060 ↗MalfunctionDec 25, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE IOL COULD NOT BE DETACHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23891626 ↗MalfunctionNov 10, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS BROKEN. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510241 ↗MalfunctionOct 23, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS DAMAGED WITH NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING ANOTHER UNSPECIFIED BACKUP LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS 1 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368895 ↗MalfunctionOct 23, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS DAMAGED WITH NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING ANOTHER UNSPECIFIED BACKUP LENS WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS 3 OF 4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368855 ↗MalfunctionOct 16, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, UPON IMPLANTATION, THE SURGEON NOTICED THAT THE HAPTIC WAS BROKEN. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23310757 ↗MalfunctionSep 15, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION THE IOL GOT STUCK WHILE EXITING THE SYSTEM, WHICH LED TO DAMAGE TO THE OPTICS AND MADE IT IMPOSSIBLE TO IMPLANT THE IOL. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051346 ↗MalfunctionAug 11, 2025Failure to Advance; Device Damaged by Another Device; Material Twisted/Bent; Failure to Advance; Device Damaged by Another Device; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER BYPASSED THE IOL ALSO WHEN ADVANCING THE IOL THE ANTERIOR HAPTIC WAS STRETCHED. THE BULB WAS ALSO TILTED TO THE RIGHT AND THE LENS WAS PARTIALLY SQUEEZED. THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY USING A BACKUP IOL. ADDITIONAL INFORMATION WAS RECEIVED, ALL THE EVENTS HAPPENED IN THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772391 ↗MalfunctionAug 11, 2025Failure to Advance; Device Damaged by Another Device; Material Twisted/Bent; Failure to Advance; Device Damaged by Another Device; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER BYPASSED THE IOL ALSO WHEN ADVANCING THE IOL THE ANTERIOR HAPTIC WAS STRETCHED. THE BULB WAS ALSO TILTED TO THE RIGHT AND THE LENS WAS PARTIALLY SQUEEZED. THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY USING A BACKUP IOL. ADDITIONAL INFORMATION WAS RECEIVED; ALL THE EVENTS HAPPENED IN THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772390 ↗MalfunctionAug 5, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER RESTRICTED MOVEMENT, DID NOT PROCEED PROPERLY. IOL WAS INSERTED AND REMOVED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715384 ↗MalfunctionJun 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS LEADING HAPTIC CAME OUT FROM THE INJECTOR TOO EARLY. SURGEON WANTED TO BE SURE THAT INJECTING WILL GO SMOOTHLY SO THEY TOOK NEW UNSPECIFIED ONE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 4 OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168823 ↗MalfunctionMay 30, 2025Failure to Advance; Failure to Advance
ADDITIONAL INFORMATION WAS RECEIVED STATING ONLY THE INJECTOR ENTERED THE EYE AS THE PLUNGER PASSED THE LENS AND THEREFORE NOT INJECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116184 ↗MalfunctionMay 30, 2025Failure to Advance; Failure to Advance
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING THE LENS THE PLUNGER FAILED TO DEPLOY THE LENS INTO THE PATIENT'S EYE. AS A RESULT, A REPLACEMENT LENS WAS USED. NO HARM OCCURRED TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22112663 ↗MalfunctionMay 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME OUT OF THE INJECTOR WITH THE LEADING HAPTIC BENT. THIS CAUSED THE LEADING HAPTIC TO STRAIGHTEN IN THE ANTERIOR CHAMBER DURING IMPLANTATION, AND THE LENS STARTED TO ROTATE IN THE WRONG DIRECTION. THE SURGERY WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DEFECT WAS NOTICED WHEN THE DOCTOR WAS ABOUT TO INSERT THE LENS INTO THE EYE. THE ANTERIOR HAPTIC OF THE LENS WAS TWISTED IN THE WRONG DIRECTION AND NOT PROTECTED BY THE OPTICAL PART OF THE LENS. THE LENS REMAINED AT THE MAIN INCISION OPENING, AS THE DOCTOR DID NOT DARE TO INSERT IT INTO THE EYE DUE TO FRAGILE STRUCTURES. THE LENS WAS THEN REMOVED FROM THE WOUND USING FORCEPS AND REPLACED WITH A NEW ONE, AS IT COULD NOT BE CONFIRMED WHETHER THE OPTICS OF THE LENS WERE STILL INTACT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084934 ↗MalfunctionMay 2, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) LEAKAGE FROM THE INJECTOR WITH DAMAGE TO THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21949816 ↗MalfunctionApr 28, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN ADVANCING THE PLUGGER IT CAUSED LENS TO OVERRIDE. THE SAME ISSUE WAS REPEATED WHEN ATTEMPTED WITH ANOTHER LENS AGAIN AND ENDED UP USING A LENS FROM A DIFFERENT BATCH WITHOUT ANY ISSUE WITH A COMPANY VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21918380 ↗MalfunctionApr 28, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN ADVANCING THE PLUGGER IT CAUSED LENS TO OVERRIDE. THE SAME ISSUE WAS REPEATED WHEN ATTEMPTED WITH ANOTHER LENS AGAIN AND ENDED UP USING A LENS FROM A DIFFERENT BATCH WITHOUT ANY ISSUE WITH A COMPANY VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21918379 ↗MalfunctionApr 25, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE HAPTIC PART OF THE LENS BROKE, PREVENTING IT FROM ENTERING THE EYE AND THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21907341 ↗MalfunctionApr 17, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SHOOTER HAS SLIPPED OVER THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21857039 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.