BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLORBLENDS UV

    MDR report key: 2223898 · Received August 18, 2011

    Report

    Report Number
    1422160-2011-00004
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CIBA VISION CORPORATION DES PLAINES
    Product Code
    LPM
    PMA / PMN Number
    P830037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE FOR EVAL. NO MFG INVESTIGATION CAN BE PERFORMED AS THE LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE PHYSICIAN, A PT WEARING CONTACT LENSES PRESENTED AT AN EMERGENCY HOSPITAL WITH AN ULCER ON THE LEFT EYE. THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE PHYSICIAN ALSO NOTIFIED THE HEALTH SCIENCES AUTHORITY (HSA) IN (B)(6). THE PHYSICIAN COULD NOT PROVIDE ADD'L INFO DUE TO THE PT ONLY RELEASING CONSENT FOR INFO TO THE HSA. ADD'L INFO HAS BEEN REQUESTED FROM HSA BUT NOT REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESHLOOK COLORBLENDS UV LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION CORPORATION DES PLAINES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R