BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CHAMBER LENS

    MDR report key: 2563214 · Received May 3, 2012

    Report

    Report Number
    1119421-2012-00582
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    January 1, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P880087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE WERE NO OTHER COMPLAINTS REPORTED IN THIS LOT. ADDITIONAL INFORMATION WAS REQUESTED BY PHONE, FAX AND MAIL ON 04/04/2012, 04/18/2012 AND 05/01/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING AGENT REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MTA5U0 10801460

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention