BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VISCOELASTIC

    MDR report key: 2468841 · Received February 22, 2012

    Report

    Report Number
    3002037047-2012-00037
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 24, 2012
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON - COUVREUR N.V.
    Product Code
    LZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED BY PHONE, FAX AND MAIL ON 01/25/2012, 01/27/2012 AND 02/10/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PT WHO EXPERIENCED A CORNEAL BURN IN CONJUNCTION WITH AN UNSPECIFIED VISCOELASTIC. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK VISCOELASTIC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / S.A. ALCON - COUVREUR N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other