BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK -- IOL

    MDR report key: 2963411 · Received February 13, 2013

    Report

    Report Number
    1119421-2013-00125
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A DIRECTOR OF A HOSPITAL REPORTED OBSERVING INTERNAL CRYSTALLIZATION IN YELLOW INTRAOCULAR LENSES AFTER THEY HAVE BEEN IMPLANTED FOR APPROXIMATELY THREE YEARS. THE DIRECTOR REPORTED THE PATIENT'S VISUAL ACUITY AND LIGHT PERCEPTION WERE AFFECTED. THE DIRECTOR KNOWS OF APPROXIMATELY THIRTY SIMILAR CASES. ONE PICTURE OF THIS EVENT WAS RETURNED, BUT NO PATIENT IDENTIFIERS WERE AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PATIENT WHOSE PICTURE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64048 UNK -- IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other