BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 2468838 · Received February 22, 2012

    Report

    Report Number
    1119421-2012-00222
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 24, 2012
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - 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. THERE WAS NOT ENOUGH INFO PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADD'L INFO WAS REQUESTED ON 01/26/2012 AND 02/03/2012. THE SURGEON IS UNABLE TO PROVIDE ADD'L INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH RESIDUAL CYLINDER FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AFTER F/U ATTEMPTS, THE SURGEON STATED HE IS UNABLE TO PROVIDE ADD'L INFO REGARDING THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other