BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF MULTIPIECE IOL

    MDR report key: 8701140 · Received June 14, 2019

    Report

    Report Number
    1119421-2019-00920
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 14, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA REPLY CARD THAT AN INTRAOCULAR LENS (IOL) WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495664 ACRYSOF MULTIPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON MA60AC 12493009

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR