BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CHAMBER LENS

    MDR report key: 2043044 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00326
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P880087
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ACTION TAKEN: FURTHER ACTION IS NOT WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THAT A SURGEON HAS A PT WHOSE INTRAOCULAR LENS (IOL) IS MOVING. ADDITIONAL INFO 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 MTA4U0 NI

    Patients

    Seq Age Sex Outcome Treatment
    1