BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 3890547 · Received June 4, 2014

    Report

    Report Number
    3006186389-2014-00021
    Event Type
    Injury
    Date Received
    June 4, 2014
    Report Date
    December 2, 2013
    Manufacturer
    CIBA VISION JOHOR SDN.BHD.
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL F/U MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).CONTROL NUMBER: 203494.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF FOUR REPORTS ON THE SAME PT INVOLVING FOUR PRODUCTS WITH DIFFERENT LOT NUMBERS. REFER TO MEDWATCH 3006186389-2014-00022, 3006186389-2014-00023, AND 3006186389-2014-00024 FOR A DESCRIPTION OF THE SUBSEQUENT REPORTS. IT IS UNK WHICH LOT WAS INVOLVED IN THE ADVERSE EVENT. A REPORT WAS RECEIVED (B)(6) 2013, FROM AN EYE CARE PROFESSIONAL (ECP) THAT APPROX THREE MONTHS PRIOR, A PT EXPERIENCED PAIN IMMEDIATELY UPON INSERTION OF CONTACT LENSES, AND SOUGHT MEDICAL ATTENTION AT A HOSPITAL. THE HOSPITAL ADVISED THAT SHE HAD A BACTERIAL INFECTION AND PRESCRIBED UNSPECIFIED DROPS FOR TREATMENT. THE ECP STATED THAT THE INCIDENT HAD RESOLVED AND THE PT HAD RESUMED LENS WEAR BUT NO LONGER USED EXTENDED WEAR CONTACT LENSES. A REQUEST WAS RECEIVED ON (B)(6) 2014, FROM THE ECP TO INQUIRE IF ANY SIMILAR INCIDENTS WERE REPORTED INVOLVING THE PRODUCT LOTS. THE PT HAD EXPERIENCED CORNEAL ULCERS RATHER THAN A BACTERIAL INFECTION, AS PREVIOUSLY REPORTED. NO INFO REGARDING DURATION OF EVENT OR TREATMENT MODALITY WAS RECEIVED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327734 AIR OPTIX AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION JOHOR SDN.BHD. 10120976

    Patients

    Seq Age Sex Outcome Treatment
    1 Other