BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2163672 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00705
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 11, 2011
    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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. SAMPLE IS PENDING RECEIPT. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. IT WILL BE REASSESSED UPON SAMPLE RECEIPT. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING SEVERE GLARE DISABILITIES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT REPORTED TO THE SURGEON THAT HE WAS A TRUCK DRIVER AND WAS EXPERIENCING SEVERE GLARE ESPECIALLY WHILE DRIVING AT NIGHT. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGICAL PROCEDURE. A LENS EXCHANGE IS PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other HEALON