BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IOL

    MDR report key: 3093798 · Received April 30, 2013

    Report

    Report Number
    1119421-2013-00457
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED IN TWO PIECES FOR EVAL. SOLUTION AND BLOOD ARE DRIED ON THE LENS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. LENS BENCH TESTING COULD NOT BE CONDUCTED BECAUSE OF THE OPTIC DAMAGE. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND BLOOD, THE OBSERVED DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING AGENT REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186969 UNK - IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention