BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - -IOL

    MDR report key: 2854768 · Received November 30, 2012

    Report

    Report Number
    1119421-2012-01487
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL 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 MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    AFTER INITIALLY REPORTING ONE PT WITH GLISTENINGS NOTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A SURGEON THEN REPORTED NINE MORE PTS. FOR THIS PT, THERE WAS NO REPORT OF VISUAL CHANGES FOLLOWING BILATERAL IOL IMPLANT SURGERIES. THE SURGEON NOTED TRACE DEPOSITS IN THIS LENS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SEVENTH PT, LEFT EYE. THE FIRST PT WAS REPORTED UNDER MFR REPORT # 1119421-2011-01438.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1