AcrySof® UltraSert® AU00T0 (UDI 00380652394840)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 intraocular lens is a foldable lens pre-loaded in an injector cartridge for cataract surgery. Most of the 34 reports describe problems with the delivery system — the injector failing to load or eject the lens, being hard to prepare, or damaging or scratching the lens or its haptics during handling — plus a few reports of parts that broke. Five reports mention injuries; no deaths. No recalls name 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
- 35
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652394840), received between Apr 27, 2021 and Sep 29, 2026 — classified as 5 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (7 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 Device7
- Device Difficult to Setup or Prepare7
- Failure to Eject7
- Failure to Advance5
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Defective Component2
- Defective Device2
Patient problems
- Insufficient Information20
- No Clinical Signs, Symptoms or Conditions12
- Eye Injury3
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Deliver
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, lens was failed to advance. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933041 ↗MalfunctionAug 4, 2026Failure to Advance; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129220 ↗MalfunctionJul 31, 2026Device Difficult to Setup or Prepare; Scratched Material
Patient problems: Insufficient Information
MAUDE report 50099192 ↗MalfunctionApr 10, 2026Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED WITH DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24844101 ↗MalfunctionMar 7, 2026Device Difficult to Setup or Prepare; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE INJECTOR DID NOT LOAD CORRECTLY AND SCRATCHED THE LENS AND THEREFORE PREVENTING THE USAGE OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24540929 ↗MalfunctionJan 7, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS IMPLANTED, A LESION WAS NOTED IN THE TEMPORAL POSITION OF THE OPTIC. THE LENS WAS REMOVED AND REPLACED WITH A SIMILAR ONE IN THE SAME PROCEDURE AND COMPLETED THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23988117 ↗MalfunctionNov 24, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED THE IOL WAS FOUND WITH ONE OF THE HAPTICS BROKEN. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT AND SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632094 ↗MalfunctionJul 17, 2025Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE DUE TO THE DUE TO A DEFECT IN THE LENS CARTRIDGE, THE LENS COULD NOT BE PUSHED OUT OF THE CARTRIDGE. AS THE LENS HAPTICS WERE DAMAGED DUE TO FORCED MANIPULATION, THE LENS WAS NOT IMPLANTED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529769 ↗MalfunctionJun 23, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE DURING THE IMPLANTATION OF A PRELOADED INTRAOCULAR LENS. THE POSTERIOR HAPTIC WAS PRESUMABLY CUT BY THE PLUNGER OF THE INJECTOR. PRIOR TO IMPLANTATION, THE POSTERIOR HAPTIC WAS BENT ONLY IN ITS DISTAL PART. THE POSTERIOR HAPTIC WAS DEFORMED (SEVERED) DURING PLACEMENT OF THE IOL INTO THE CAPSULAR BAG. THE DAMAGED IOL WAS CUT AND REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH SIMILAR IOL.
Patient problems: Insufficient Information
MAUDE report 22307759 ↗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 HAPTIC JAMMED IN DELIVERY SYSTEM. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE BACK UP LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967256 ↗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 THE LENS WAS COMPLETELY STRAIGHT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21949123 ↗MalfunctionApr 21, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE INJECTOR GOT STUCK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21875308 ↗InjuryApr 2, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL DEFECTS WERE OBSERVED ON THE OPTIC EDGE AFTER IMPLANTATION. LENS WAS EXPLANTED IN SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21754031 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, THE POSTERIOR CAPSULE RUPTURED UPON DELIVERY OF LENS INTO THE EYE . HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Capsular Bag Tear
MAUDE report 21641745 ↗MalfunctionMar 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, A PIECE OF HAPTIC WAS STUCKED IN THE CARTRIDGE, THE LENS COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582234 ↗MalfunctionDec 3, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL), BROKEN. A NEW ONE WAS TAKEN TO REPLACE IT WITH NO PERSONAL INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20834757 ↗MalfunctionSep 26, 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 DAMAGED, COULD NOT INJECT ALL THE WAY THROUGH THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20309058 ↗InjurySep 24, 2024Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HE HAD TO WIDEN THE INCISION FOR EVERY SUSPECT DEVICE USED. THE SURGEON STATED THAT THE USUAL INCISION SIZE WAS 2.4 MM, BUT THIS WASN'T ENOUGH FOR THE SUSPECT DEVICE, SO HE HAD TO WIDEN THE INCISION TO 2.5 TO 2.6 MM TO INSERT THE CARTRIDGE TIP INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT, BUT NO IMPACT ON THE PATIENT AS THE CATARACT OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS AFTER THE INCISIONS WERE WIDENED. THERE ARE SEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 3 OF 7.
Patient problems: Eye Injury
MAUDE report 20291433 ↗MalfunctionJun 28, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED NOT USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19631360 ↗InjuryMay 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON OBSERVED WHITE DEPOSITS ALL OVER EDGES OF THE LENS SUBSEQUENTLY THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND SENT TO LABORATORY FOR MICROBIOLOGY. FORTUNATELY NO GROWTH WAS FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE SURGERY WAS COMPLETED BY REMOVING THE FAULTY LENS FROM THE EYE AND REPLACED IT WITH THE SAME MODEL. PATIENT SUFFERED SOME IRIS TRAUMA AS A CONSEQUENCE OF EXPLANTING THE LENS AND HAD TO USE MALYUGIN RING DURING THE LENS EXCHANGE PROCEDURE, ALSO SUTURES WERE NEEDED.
Patient problems: Eye Injury; Insufficient Information
MAUDE report 19358181 ↗MalfunctionMay 15, 2024Failure to Fold; Defective Component; Device Damaged by Another Device; Failure to Fold; Defective Component; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT FOLD CORRECTLY, LEG WENT FORWARD AND THE LENS WAS DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19319283 ↗MalfunctionMay 14, 2024Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE PLUNGER WENT OVER THE BODY OF THE LENS AND DAMAGED IT IN THE PROCESS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19310293 ↗MalfunctionMay 1, 2024Defective Device; Defective Device
A OTHER HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19220262 ↗MalfunctionMar 19, 2024Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF PROBLEMS IN ENGAGING THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18932060 ↗MalfunctionNov 3, 2023Failure to Eject; Failure to Eject
A PHARMACY INTERN REPORTED WITH A DESCRIPTION OF THE INJECTOR HAS BEEN INCORRECTLY POSITIONED AND PLACED ON TOP OF THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18066352 ↗
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.