AcrySof® UltraSert® AU00T0 (UDI 00380652394703)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 lens is an artificial lens implanted in the eye during cataract surgery using a preloaded injector. Reports mostly describe the lens failing to move through the injector or the small arms breaking or getting stuck, so surgery was finished with a replacement lens. There are 23 reports naming its identifier, with no deaths and 2
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
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652394703), received between Nov 27, 2019 and Apr 23, 2026 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (9 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
- Failure to Advance9
- Device Difficult to Setup or Prepare6
- Device Damaged by Another Device5
- Failure to Eject5
- Defective Component2
- Defective Device2
- Failure to Fold2
- Inaccurate Delivery1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions9
- Blurred Vision1
- Capsular Bag Tear1
- Macular Edema1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PISTON WAS PRESSED TOO MUCH AND IT DID NOT TAKE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 4.
Patient problems: Insufficient Information
MAUDE report 24966668 ↗MalfunctionApr 23, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PISTON WAS PRESSED TOO MUCH AND IT DID NOT TAKE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 4.
Patient problems: Insufficient Information
MAUDE report 24966666 ↗MalfunctionJan 27, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED FAULTY HAPTIC AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING NON COMPANY LENS. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 3 FILES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188888 ↗MalfunctionDec 30, 2025Failure to Fold; Device Difficult to Setup or Prepare; Device Damaged by Another Device; Failure to Fold; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED AS USUAL ACCORDING TO ROUTINE WITH VISCOELASTIC. THE FRONT HAPTIC DID NOT WANT TO FOLD, AND THE REAR HAPTIC GOT STUCK IN THE CARTRIDGE AND BROKE JUST AS THE LENS WAS ABOUT TO BE INSERTED INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PRODUCT CAME INTO CONTACT WITH THE EYE BUT WAS NOT INJECTED. THE PROCEDURE WAS COMPLETED, BUT WITH A DIFFERENT LENS.
Patient problems: Insufficient Information
MAUDE report 23931447 ↗MalfunctionAug 7, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT ADVANCE AND HAD LEADING HAPTIC ISSUE. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736541 ↗MalfunctionJul 21, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS, DAMAGED BOTH LENS AND THE POSTERIOR HAPTIC, AND CONSEQUENTLY THE LENSES COULD NOT BE INSERTED. THE SURGERY WAS COMPLETED WITH A SECOND LENS, AND AN ADDITIONAL VISCOELASTIC WAS OPENED. THE COMPANY VISCOELASTIC USED, WHICH HAD BEEN AT ROOM TEMPERATURE FOR ONE HOUR PRIOR TO THE PROCEDURE. THE LENS WAS PREPARED IMMEDIATELY BEFORE USE. THE LENS WAS NOT IN CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555703 ↗MalfunctionJul 19, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device
AN ADMINISTRATOR/SUPERVISOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT OVER THE LENS, DAMAGING BOTH LENS AND THE POSTERIOR HAPTICS WITH NO PATIENT CONTACT, AND CONSEQUENTLY THE LENSES COULD NOT BE INSERTED. THE SURGERY WAS COMPLETED WITH A SECOND LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22550196 ↗MalfunctionMay 23, 2025Device Damaged by Another Device; Device Damaged by Another Device
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE PATIENT UNDERWENT CATARACT SURGERY ON THE RIGHT EYE. AFTER PLACEMENT OF AN IMPLANT IN THE ALREADY FISSURED BAG AT THE EXIT OF THE INJECTOR APPROXIMATELY 1 MM AT THE EXTREME PERIPHERY OF OPTICS AND DECIDED TO LEAVE IT IN PLACE BECAUSE THE CRACK WAS OUTSIDE THE OPTICAL AXIS.
Patient problems: Insufficient Information
MAUDE report 22075819 ↗MalfunctionMay 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 22004273 ↗MalfunctionJan 9, 2025Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED TO DISCHARGE FROM APPLICATOR CORRECTLY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNKNOWN REPLACEMENT LENS OF SAME SIZE. THERE WAS NO PATIENT HARM. THERE ARE MULTIPLE MEDICAL REPORTS ASSOCIATED WITH DIFFERENT EVENTS. THIS FILE IS 6 OF 9.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111896 ↗MalfunctionJan 9, 2025Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED TO DISCHARGE FROM APPLICATOR CORRECTLY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNKNOWN REPLACEMENT LENS. THERE WAS NO PATIENT HARM. THERE ARE MULTIPLE MEDICAL REPORTS ASSOCIATED WITH DIFFERENT EVENTS. THIS FILE IS 7 OF 9.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21110235 ↗MalfunctionOct 10, 2024Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED TWO PRELOADED DEVICES WHICH WERE DEFECTIVE - THE PLUNGER WENT OVER THE TOP OF THE LENS IN BOTH INSTANCES, NOT ENGAGING WITH THE HAPTICS AS IT SHOULD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20419942 ↗MalfunctionOct 10, 2024Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED TWO PRELOADED DEVICES WHICH WERE DEFECTIVE - THE PLUNGER WENT OVER THE TOP OF THE LENS IN BOTH INSTANCES, NOT ENGAGING WITH THE HAPTICS AS IT SHOULD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20419848 ↗MalfunctionMay 20, 2024Failure to Fold; Device Difficult to Setup or Prepare; Defective Component; Device Damaged by Another Device; Failure to Fold; Device Difficult to Setup or Prepare; Defective Component; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) DID NOT FOLD CORRECTLY, THE LEG WENT FORWARD AND THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19348894 ↗MalfunctionMar 28, 2024Failure to Eject; Failure to Eject
A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS INJECTOR FAILED AND LENS HAPTIC GOT STUCK. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND UPDATED.
Patient problems: Insufficient Information
MAUDE report 18997126 ↗MalfunctionNov 28, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) ON A ROLL IN THE HOLDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18214148 ↗MalfunctionOct 25, 2021Failure to Eject; Failure to Eject
A MATERIALS COORDINATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR SLID OVER TOP OF LENS. PATIENT CONTACT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IN SURGEON¿S OPINION, THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12692494 ↗MalfunctionOct 14, 2021Failure to Eject; Failure to Eject
A HEALTH PROFESSIONAL REPORTED THAT THE INJECTOR WAS OVERRIDING THE IOL. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND REPORTED THAT THE EVENT OCCURRED DURING SURGERY AND THERE WAS A PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12635926 ↗InjuryAug 13, 2021Defective Component; Malposition of Device; Defective Component; Malposition of Device
ADDITIONAL INFORMATION REQUESTED, RECEIVED AND REPORTED, THAT THE PATIENT EXPERIENCED CYSTOID MACULAR EDEMA (CME) AND HAPTIC ISSUE. THE SURGEON PROGNOSIS WAS GOOD.
Patient problems: Blurred Vision; Macular Edema
MAUDE report 12319785 ↗InjuryMay 25, 2021Inaccurate Delivery; Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, DURING IOL LOADING THE PLUNGER SUDDENLY FORCED THE IOL INSIDE THE CAPSULAR BAG AND CAUSED A RENT. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT LENS MODEL.
Patient problems: Capsular Bag Tear
MAUDE report 11873956 ↗MalfunctionMar 7, 2021Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE NOZZLE WAS FOUND TO BE "DEFECTIVE." THE IOL WAS IMPLANTED WITH NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11426374 ↗MalfunctionMar 2, 2021Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT THE "LENS WAS STUCK" DURING A RIGHT EYE INTRAOCULAR LENS IMPLANTATION PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11399978 ↗MalfunctionNov 27, 2019Failure to Advance
AN AU00T0 17.0D LENS WOULD NOT DEPLOY FROM THE HAND PIECE , THESE ARE THE FOLDER LENSES INSIDE IT'S OWN ONE TIME USE INSERTER, A 2ND LENSE OF THE SAME DIOPTER AU00T0 17.0D WAS CHOSEN AND INSERTED. PROCEDURE IN DETAIL: NO MENTION IN PROCEDURAL NOTES OF MALFUNCTION, ONLY END RESULT THAT THE IOL WAS INSERTED. NOTES AS FOLLOWS: "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND POSITIONED ON THE OPERATING TABLE. A FEW DROPS OF PROPARACAINE WERE PLACED ON THE OPERATIVE EYE. THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A LIEBERMAN EYELID SPECULUM WAS POSITIONED ON THE OPERATIVE SIDE. A TEMPORAL APPROACH WAS USED. COUNTER TRACTION WITH A COTTON TIP APPLICATOR WAS APPLIED AS A PARACENTESIS INCISION WAS THEN INCISED 2-3 CLOCK HOURS CLOCKWISE OF THE PLANNED CORNEAL INCISION WITH A 1.0 MM CLEAR CUT SIDEPORT BLADE. LESS THAN 1.0 CC OF STERILE EPI-SHUGARCAINE WAS INSTILLED INTO THE ANTERIOR CHAMBER. DISPERSIVE VISCOELASTIC WAS THEN INSTILLED VIA THE PARACENTESIS TO FILL THE ANTERIOR CHAMBER. THE VISCO CANNULA WAS USED TO STABILIZE THE GLOBE AND A TUNNELED CLEAR CORNEAL INCISION WAS INCISED TEMPORALLY, 1 MM ANTERIOR TO THE LIMBAL ARCADE, USING A 2.4 MM CLEAR CUT SLIT BLADE. T
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9383104 ↗
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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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