AcrySof® UltraSert® ACU0T0 (REF ACU0T0.210)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 plastic lens used to replace the eye's natural lens during cataract surgery, delivered through a pre-loaded cartridge. The 46 reports mostly describe delivery problems during surgery: the cartridge plunger advancing past the lens instead of pushing it out, the lens sticking or failing to eject, packaging arriving open or loose, and haptics (the small arms) twisted, broken or not deploying. There are 45 malfunctions and 1 injury, with 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
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00380652395274), received between Mar 31, 2021 and Sep 25, 2026 — classified as 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (15 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 Advance15
- Device Difficult to Setup or Prepare9
- Defective Device6
- Failure to Eject5
- Failure to Deliver3
- Break2
- Device Damaged by Another Device2
- Failure to Fold2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information17
- Eye Injury1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during priming the device for a cataract surgery involving intraocular lens (IOL) implantation, it was observed that the haptic was not placed correctly in the cartridge. The surgery was completed on the same day. There was no patient harm.No further details are expected, as the reporter has no more information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897337 ↗MalfunctionJul 1, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A FAULTY LENS TRAILING BEHIND THE PLUNGER WAS OBSERVED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. NO FURTHER DETAILS ARE EXPECTED, AS THE REPORTER HAS NO MORE INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678112 ↗MalfunctionMay 11, 2026Failure to Advance; Device Damaged by Another Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE LENS WAS JAMMED IN THE INJECTOR, AND IT WAS ALSO NOTICED THAT THE HAPTIC WAS BROKEN. SURGERY WAS COMPLETED ON THE SAME DAY WITH A NEW LENS. IOL WAS DISCARDED. 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 25137421 ↗MalfunctionMay 11, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, TRAILING HAPTIC DID NOT DEPLOY PROPERLY AND APPEARS TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135900 ↗MalfunctionApr 2, 2026Device Difficult to Setup or Prepare; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A FAULTY LENS HAD BEEN OBSERVED. THE SURGERY WAS COMPLETED USING ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766802 ↗MalfunctionMar 13, 2026Failure to Prime; Scratched Material
A PHARMACIST REPORTED THAT BEFORE THE INTRAOCULAR LENS IMPLANT LENS PROCEDURE, THAT THERE WAS SCRATCHED DISC OF THE LENS CAUSED BY A PUSHER THAT DOES NOT MOVE LINEARLY. NO FURTHER INFORMATION WAS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589677 ↗MalfunctionFeb 11, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTICED THAT THE LENS APPLICATOR WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24312979 ↗MalfunctionJan 13, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE PLUNGER NEVER ENGAGED WITH THE LENS. SURGERY WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051654 ↗MalfunctionJan 8, 2026Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS BENT / PLUNGER SLIDES UNDER/OVER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING NO HOSPITALIZATION NECESSARY AS A RESULT OF THE EVENT AND THE EVENT DID NOT RESULT IN ANY IMPAIRMENT OF THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH THE SAME IOL, WITHOUT REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24016661 ↗MalfunctionDec 31, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR HAPTIC WAS STRETCHED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE EVENT OCCURRED BEFORE SURGERY AND THERE WAS NO PATIENT CONTACT. THE SURGERY COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933694 ↗MalfunctionDec 30, 2025Failure to Advance; Failure to Advance
A PHYSICIAN REPORTED WITH A DESCRIPTION, AFTER THE LENS WAS INITIALLY LOADED AND AS IT APPROACHED THE CARTRIDGE MOUTH, THE PUSH SLIDER DISENGAGED THE LENS AND PASSED UNDERNEATH IT. WHEN ATTEMPTING TO REMOVE IT FOR RELOADING, THE BLUE PUSH SLIDER APPEARED DAMAGED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A REPLACEMENT LENS OF SAME MODEL AND POWER AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920947 ↗MalfunctionDec 1, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC FOLDED WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678230 ↗MalfunctionNov 21, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC BECAME STUCK IN THE PLUNGER WHILE BEING INJECTED INTO THE EYE. AS A RESULT, THE LENS WAS ONLY PARTIALLY DELIVERED. THE SURGERY WAS COMPLETED USING A NEW LENS, AND THERE WAS NO HARM TO THE PATIENT ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616016 ↗MalfunctionNov 11, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR FAILED TO PUSH THE LENS FORWARD. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23521610 ↗MalfunctionOct 24, 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, TRAILING HAPTIC WAS FAULT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED, TRAILING HAPTIC DID NOT FOLD CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379339 ↗MalfunctionSep 2, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER DID NOT WORK. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22944302 ↗MalfunctionSep 2, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE TRAILING HAPTIC WAS OBSERVED TO BE TWISTED AND STUCK UNTO THE PLUNGER AFTER PRIMING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22937554 ↗MalfunctionAug 14, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS JAMMED IN INJECTOR. HENCE IT WAS REMOVED USING FORCEPS AND IMPLANTED MANUALLY.
Patient problems: Insufficient Information
MAUDE report 22805774 ↗MalfunctionAug 11, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE PLUNGER SEEMED TO OVERRIDE THE LENS AND FAILED TO DELIVER INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED WITH ANOTHER LENS. THERE WAS A PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770496 ↗MalfunctionJul 1, 2025Break; Break
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN OR MISSING. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED WITH REPLACEMENT LENS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370795 ↗MalfunctionJun 6, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE UPON LOADING THE LENS AND THE HAPTIC WAS DAMAGED OR JAMMED IN DELIVERY SYSTEM. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE DISTAL LOOP OF LENS WAS BROKEN DURING INSERTION. THERE WAS NO PATIENT CONTACT AND SURGERY COMPLETED WITH REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157518 ↗MalfunctionMay 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED A DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22070539 ↗MalfunctionApr 25, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY INTRAOCULAR LENS (IOL) BLOCKED IN THE INJECTOR. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908747 ↗MalfunctionMar 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED WITH A DESCRIPTION OF DEFECTIVE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21690511 ↗MalfunctionNov 5, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY LENS OPENING SIDEWAYS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 20608387 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
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- 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 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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