BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CHAMBER LENS

    MDR report key: 2669917 · Received July 20, 2012

    Report

    Report Number
    1119421-2012-00910
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    January 1, 2012
    Report Date
    June 21, 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
    MA, US
    Reporter Occupation
    OTHER

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADD'L INFO WERE DONE ON 06/25/2012 AND 07/10/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN ASSISTANT REPORTED AN INTRAOCULAR LENS (IOL) IMPLANT WAS REMOVED FOLLOWING COMPLICATION OF CHOROIDAL HEMORRHAGE, DURING SURGERY. ADD'L 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 10970796

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other