BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM

    MDR report key: 11777696 · Received May 5, 2021

    Report

    Report Number
    9612169-2021-00107
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    January 25, 2021
    Report Date
    August 18, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394734
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. H.3. D.9. D.10. AND H.10. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT COULD NOT BE OBSERVED. IOL WAS RETURNED OUTSIDE THE DEVICE. THE DEVICE WAS RETURNED IN THE BLISTER TRAY INSIDE THE CARTON. THE LENS STOP AND THE PLUNGER STOP HAVE BEEN REMOVED. THE PLUNGER IS ORIENTED CORRECTLY. VISCOELASTIC IS OBSERVED IN THE DEVICE. THE PLUNGER HAS BEEN RETRACTED INTO THE MID NOZZLE. NO DAMAGE OBSERVED TO THE DEVICE. THE IOL IS ATTACHED TO THE NOZZLE TIP WITH SOLUTION. THE LENS IS SCRATCHED/MARKED-REJECTABLE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY THE ROOT CAUSE FOR THE REPORTED COMPLAINT "INJECTOR RIDING OVER THE IOL" AS LENS WAS RETURNED OUTSIDE THE DEVICE. DUE TO THIS, WE ARE UNABLE TO CONFIRM LENS AND HAPTIC POSITION FOR ADVANCEMENT AND DETERMINE A ROOT CAUSE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. NO OTHER COMPLAINTS REPORTED IN THE LOT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    THE REPRESENTATIVE REPORTED THAT THEY HAVE EXPERIENCED ISSUES WITH THE INJECTORS RIDING OVER THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674422 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21272175 00380652394734

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE| PROVISC