BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1760699 · Received July 15, 2010

    Report

    Report Number
    9681121-2010-00018
    Event Type
    Injury
    Date Received
    July 15, 2010
    Report Date
    June 17, 2010
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE WAS NO PRODUCT RETURNED OR LOT INFORMATION PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED. THE PRODUCT HAS BEEN REPORTED TO HAVE BEEN RECEIVED BY THE USER FROM AN UNAUTHORIZED SOURCE (ANOTHER CONSUMER). LIMITED AND/OR LACK OF DETAILED INFORMATION IS KNOWN FOR THIS EVENT, THEREFORE, IT IS CONSIDERED TO BE SERIOUS AND REPORTABLE AS A POSSIBLE SERIOUS INJURY REQUIRING MEDICAL INTERVENTION. (B)(4)

    Description of Event or Problem · 1

    AN EYE CARE PRACTITIONER HAS REPORTED THAT A REPORT WAS RECEIVED FROM AN INSURANCE COMPANY THAT A PATIENT EXPERIENCED AN UNSPECIFIED EYE INJURY ASSOCIATED WITH A MALPRACTICE LEGAL SUIT. THE PATIENT WAS NEVER SEEN AT THEIR OFFICE AND WAS DISPENSED LENSES THROUGH ANOTHER CONSUMER. FURTHER INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT. CIBA VISION BATAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention