AcrySof® UltraSert® ACU0T0 (REF ACU0T0.220)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 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is a foldable lens for cataract surgery, delivered through a preloaded injector. The 49 reports mostly describe delivery problems during surgery: the injector failing to unlock, unlock resistance, the lens sticking or not ejecting, and the soft lens arms stretching or folding the wrong way. Three reports involve injuries and no deaths. There are no recalls naming this device, and reports in the past 12 months (6) are fewer than the 18 in the prior12 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
- 49
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00380652395298), received between Jul 6, 2021 and Apr 17, 2026 — classified as 3 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (11 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance11
- Device Difficult to Setup or Prepare9
- Failure to Eject8
- Defective Device4
- Device Damaged by Another Device4
- Failure to Deliver4
- Failure to Unfold or Unwrap3
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information21
- Capsular Bag Tear2
- Eye Injury1
- Eye Pain1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT THE INJECTOR COULD NOT BE UNLOCKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24912009 ↗MalfunctionMar 30, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS PLUNGER RESISTANCE AND IOL COULD NOT BE INJECTED SMOOTHLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24715585 ↗MalfunctionDec 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BOTH HAPTICS ARE STRETCHED (POSTERIOR PAST THE STAMP) WAS NOTICED WHILE ADVANCING THE IOL. THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862920 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN ADVANCING THE IOL IN THE DEVICE, THE POSTERIOR HAPTIC WAS PUSHED OVER THE IOL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857909 ↗MalfunctionNov 24, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) INJECTOR FAILED TO DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23630613 ↗MalfunctionNov 10, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT ONE OF THE HAPTICS WOULDN'T OPEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PLUNGER WOULD NOT ENGAGE WITH THE LENS. THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510573 ↗MalfunctionOct 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAILED IN THE THEATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23434377 ↗MalfunctionSep 19, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE PLUNGER DID NOT ENGAGE WITH THE LENS. TEMPERATURE WAS WITHIN THE RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGERY WAS COMPLETED WITH THE NEW LENS. LOW HARM WAS NOTED.
Patient problems: Insufficient Information
MAUDE report 23093536 ↗MalfunctionAug 29, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS BENT AND OVERRIDES THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921878 ↗MalfunctionAug 27, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE DISTAL LOOP WAS BROKEN DUE TO THE RIGIDITY OF THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22902632 ↗MalfunctionAug 14, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FAULTS WERE LENS TRAPPED UNDER THE PLUNGER AND THEREFORE NOT COMING OUT OF THE INJECTOR. THERE WAS PATIENT CONTACT AND NO PATIENT HARM. THE PROCEDURE COMPLETED ON THE SAME DAY WITH ANOTHER LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804351 ↗MalfunctionJul 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE LENS WAS NOT IMPLANTED BECAUSE LENS INJECTED OUTSIDE THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED WITH THE BACKUP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478917 ↗MalfunctionJul 3, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE TRAILING HAPTIC WAS BROKEN UPON INSERTION INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22394132 ↗MalfunctionJun 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS HAD A TEAR AND DID NOT STAY INSIDE THE EYE. THE LENS WAS EXPLANTED AND DISCARDED, REPLACED WITH UNSPECIFIED ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22352717 ↗MalfunctionJun 16, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS DID NOT COME OUT WHEN TRYING TO IMPLANT IN THE ANTERIOR CHAMBER. HENCE A NEW LENS WAS USED TO COMPLETE THE SURGERY. HOWEVER, THE PATIENT'S SURGERY WAS SLIGHTLY LONGER.
Patient problems: Insufficient Information
MAUDE report 22211845 ↗MalfunctionJun 12, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, TRAILING HAPTIC WOULD NOT RELEASE FROM IOL SURFACE. SURGEON HAD TO CUT LENS OUT AND USE A NEW IOL. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE FIRST IOL TRAILING HAPTIC WAS FIRMLY STUCK ONTO OPTIC AND WOULD NOT RELEASE DESPITE USING FORCEPS TO TRY TO PEEL IT OFF WHILE STABILIZING THE OPTIC WITH A SECOND INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 22195244 ↗MalfunctionMay 30, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, ON ADVANCEMENT OF LENS IN CHAMBER OF INJECTOR, FOLLOWING INJECTION OF VISCOELASTIC, IT WAS NOTED THAT THE LENS WAS ADVANCING UNCONVENTIONALLY. ALTERNATIVE LENS WAS USED. NO HARM CAUSED TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, IT HAD A LEADING HAPTIC AND TRAILING HAPTIC ISSUE, AND THE CENTER OF THE LENS BUNCHED UP AS OPPOSED TO ROLLING UP LIKE IT USUALLY WOULD DO. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115558 ↗MalfunctionMay 22, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF A FAULTY LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069980 ↗MalfunctionApr 30, 2025Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21935893 ↗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 2 OF 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775301 ↗MalfunctionMar 26, 2025Failure to Deliver; Failure to Advance; Material Twisted/Bent; Failure to Deliver; Failure to Advance; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INSERTING THE LENS, THE BLUE CURSOR WAS CAUSING FRICTION AND DID NOT SLIDE CORRECTLY. SO THE LENS REMAINED STUCK IN THE TUNNEL AND WITH THE SECOND HAPTIC FOLDED OVER ON ITSELF. THE SURGERY WAS COMPLETED BY USING COMPANY ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695988 ↗MalfunctionJan 28, 2025Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL BLOCKED IN THE INJECTOR. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21251332 ↗MalfunctionDec 3, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS FAULTY, PART OF THE LENS WAS STUCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20829321 ↗MalfunctionNov 28, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PLUNGER WENT OVER THE LENS OR PLUNGER OVER RIDE OR PLUNGER BY PASSED THE IOL AND DID NOT DEPLOY AND LENS WAS DAMAGED DUE TO PLUNGER RUN OVER TOP OF LENS INSTEAD OF PUSHING THE LENS OUT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Insufficient Information
MAUDE report 20805106 ↗MalfunctionSep 4, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A OPHTHALMIC ASSISTANT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR FELT HARD TO PUSH AND THEN JOLTED RESULTING IN THE LENS FORCEFULLY ENTERING THE EYE CAUSING PAIN. LENS WAS LEFT IMPLANTED FROM FAULTY INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Pain
MAUDE report 20134273 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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