AcrySof® UltraSert® ACU0T0 (REF ACU0T0.225)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 foldable implant used in cataract surgery, delivered through a preloaded cartridge. The 43 reports mostly describe delivery problems during surgery: the lens sticking in the injector, failing to advance or eject, haptics folding the wrong way, and plungers slipping or passing over the lens, sometimes forcing the surgeon to use a different lens. Two injuries and no deaths were reported. 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
- 43
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00380652395304), received between Apr 8, 2021 and Mar 17, 2026 — classified as 2 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Defective 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. 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
- Defective Device7
- Failure to Eject7
- Failure to Advance6
- Device Difficult to Setup or Prepare5
- Failure to Deliver4
- Failure to Fold3
- Failure to Unfold or Unwrap3
- Inaccurate Delivery3
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Failure to Advance; Detachment of Device or Device Component; Scratched Material
A PHYSICIAN REPORTED AN ISSUE THAT OCCURRED DURING A CATARACT SURGERY INVOLVING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL). AT THE IOL INSERTION STAGE, THEY OBSERVED THAT THE PLUNGER OF THE IOL CARTRIDGE WAS LOOSE AND HAD FALLEN BACK INTO THE TRAY. THEY REINSERTED THE PLUNGER AND DEPRESSED IT, AT WHICH POINT IT WAS NOTICED THAT THE DISTAL END HAD ADVANCED PAST THE LENS. THE PLUNGER WAS THEN REMOVED, ROTATED AT 180°, AND READVANCED. FOLLOWING THIS ADJUSTMENT, THE LENS ADVANCED THROUGH THE CARTRIDGE AS EXPECTED. ONCE THE IOL WAS PLACED IN THE EYE, A CENTRAL SCRATCH ON THE LENS WAS IDENTIFIED. THEY RECONFIRMED THE PRESENCE OF SCRATCH BY ASPIRATING IN FRONT OF AND BEHIND THE LENS; THE DEFECT REMAINED PERSISTENT. AS A RESULT, THE LENS WAS EXPLANTED AND REPLACED WITH A NEW LENS IN AN INITIAL PROCEDURE. THE PHYSICIAN SUSPECTS THAT THE SCRATCH WAS CAUSED DUE TO INITIAL ADVANCEMENT OF THE PLUNGER IN THE INCORRECT ORIENTATION¿ALLOWING THE DISTAL END TO PASS BEYOND THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24614662 ↗MalfunctionJan 8, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS PRIMING, TRAILING HAPTIC FOLDED WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004175 ↗MalfunctionDec 24, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS STUCK AND COULD NOT BE UNFOLDED THEREFORE, IT WAS REMOVED FROM THE EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING AN UNSPECIFIED LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887513 ↗MalfunctionNov 26, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE PLUNGER DID NOT ENGAGE WITH THE LENS AND WENT OVER IT, INDICATING A FAULT. THE SURGERY WAS ABLE TO BE COMPLETED USING ANOTHER LENS. NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655087 ↗MalfunctionNov 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE EVENT OCCURRED DURING THE LOADING. THERE WAS NO PATIENT CONTACT WITH THE IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523098 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS STUCK IN THE INJECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT OR HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PATIENT USING A DIFFERENT NEW LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664849 ↗MalfunctionJul 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS STIFF TO INJECT. SURGEON WAS NOT HAPPY TO IMPLANT AND USED ANOTHER LENS WHICH WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22540391 ↗MalfunctionJul 16, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS NOT IMPLANTED DUE TO OF TOO MUCH PRESSURE IN THE EYE AND THE LENS WAS DID NOT INJECT PROPERLY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE SURGERY WAS COMPLETED WITH BACK UP LENS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22520270 ↗MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC WENT AROUND THE LENS AS IT WAS GETTING PRIMED. NOTED WHEN THE LENS WAS BEING LOADED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22433916 ↗MalfunctionJun 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON UNABLE TO DELIVER THE LENS INTO THE BAG DUE TO FAULTY PLUNGER. PLUNGER VERY HARD AND STIFF TO PRESS. ALTERNATIVE LENS INSERTED WITHOUT ANY PROBLEMS. NO HARM CAUSED TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187239 ↗MalfunctionJun 10, 2025Device Damaged by Another Device; Device Damaged by Another Device
THE SURGEON REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CRUMPLED WITHIN THE DELIVERY CHAMBER. THE SURGERY COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177518 ↗MalfunctionApr 4, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) PRIMING, LENS STUCK IN DELIVERY SYSTEM AND TRAILING HAPTIC FOLDED WRONG. LENS DID NOT COME OUT, IT WAS BLOCKED. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 1 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775309 ↗MalfunctionMar 26, 2025Failure to Fold; Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE WAS FAULTY, HAPTIC WAS NOT FOLDED WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND STATED THAT THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21699477 ↗MalfunctionMar 21, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY WHILE TRYING TO LOAD THE LENS, THE BLUE PLUNGER DID NOT ENGAGE WITH THE LENS WITHIN THE PRE-LOADED DELIVERY SYSTEM, WHILST THE BLUE PLUNGER DID ADVANCE, THE LENS REMAINED IN THE BODY OF THE DELIVERY SYSTEM. THE SURGERY WAS ABLE TO CONTINUE BY A NEW UNSPECIFIED LENS OF THE SAME DIOPTER. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663977 ↗MalfunctionNov 22, 2024Failure to Fold; Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, THE ITEM DOES NOT LOAD PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20759013 ↗MalfunctionNov 14, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20685338 ↗MalfunctionAug 29, 2024Failure to Eject; Failure to Eject
A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS STUCK IN INJECTOR WITH NO PATIENT HARM. SAMPLE WAS DISCARDED. NON COMPANY VISCOELASTIC USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20102368 ↗MalfunctionAug 23, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL GOT STUCK AND WOULD NOT INSERT INTO THE EYE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20046778 ↗MalfunctionJul 12, 2024Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) INJECTOR STUCK. THE LENS WAS NOT INJECTED INTO THE EYE.
Patient problems: Insufficient Information
MAUDE report 19730419 ↗MalfunctionApr 16, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PROCEDURE WAS COMPLETED WITH THE ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19114195 ↗MalfunctionFeb 20, 2024Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON IMPLANTATION THE LENS ONLY WENT HALF IN THE PATIENT'S EYE, AND HAD TO BE REMOVED WITH FORCEPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738745 ↗InjuryNov 9, 2023Defective Component; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC GOT STUCK BETWEEN INSERTION AND INCISION, IT STUCK ON INJECTOR END INSIDE EYE. THE PROCEDURE WAS COMPLETED BY WIDENING THE INCISION AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 18099078 ↗MalfunctionOct 6, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17886772 ↗MalfunctionAug 4, 2023Defective Device; Defective Device
A NURSING CHIEF REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL CAME DEFECTIVE INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE ELEVEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS FOR 06 OF 11.
Patient problems: Insufficient Information
MAUDE report 17456564 ↗InjuryFeb 26, 2023Difficult to Advance; Difficult to Advance
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON UNABLE TO INSERT LENS. THE SURGERY WAS NOT COMPLETED, THE PATIENT REFERRED TO ALTERNATIVE CONSULTANT. OPERATIVE TIME WAS EXTENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16441138 ↗
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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 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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