BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11776153 · Received May 5, 2021

    Report

    Report Number
    9612169-2021-00105
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 24, 2021
    Report Date
    August 18, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394826
    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

    CORRECTION: ON INITIAL MDR THE PRODUCT PROBLEM CODE OF 2339 WAS AN ERROR. IT SHOULD HAVE BEEN 4010 ON THE ORIGINAL MDR. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. THE DEVICE WAS RETURNED LOOSE IN 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 IS ADVANCED OUTSIDE THE TIP OF THE NOZZLE. A STRESS IS OBSERVED ON THE TIP OF THE NOZZLE. ONE HAPTIC IS BROKEN/TORN AND IS PRESENT BETWEEN THE PLUNGER AND THE NOZZLE WALL WITH THE DISTAL PORTION FACING THE LENS BAY. THE REMAINING LENS IS NOT RETURNED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY THE ROOT CAUSE FOR THE REPORTED COMPLAINT. BROKEN HAPTIC WAS RETURNED IN THE DEVICE WITH THE PLUNGER FULLY ADVANCED. THE PLUNGER POSITION IN RELATION TO THE BROKEN HAPTIC DURING THE ADVANCEMENT CANNOT BE DETERMINED. IN ADDITION TO THIS, DAMAGE WAS OBSERVED TO THE TIP OF THE NOZZLE. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. ONE OTHER COMPLAINT HAS BEEN NOTED. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. 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 FACILITY REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED ISSUES WITH THE "INJECTORS RIDING OVER THE IOL ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671848 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21271111 00380652394826

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC| PROVISC