BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2421350 · Received January 16, 2012

    Report

    Report Number
    1119421-2012-00069
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    January 1, 2011
    Report Date
    December 16, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 MANUFACTURING DOCUMENTATION. THE ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFO WAS REQUESTED ON 12/20/2011, 12/21/2011, AND 01/03/2012 BY PHONE, FAX, AND MAIL. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other