BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE COMFILCON A

    MDR report key: 2931895 · Received January 28, 2013

    Report

    Report Number
    9614392-2013-00007
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    August 23, 2011
    Report Date
    January 4, 2013
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION WAS DONE ON THE DEVICE AS IT WAS NOT RETURNED TO THE MANUFACTURER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL OR THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PATIENT WAS SEEN BY PHYSICIAN (B)(6) 2011 FOR A CORNEAL ABRASION/INFECTION IN THE LEFT EYE. PATIENT WAS THEN SEEN BY ANOTHER PHYSICIAN FOR 7 CONSECUTIVE OFFICE VISITS BETWEEN (B)(6) 2011. PATIENT WAS GIVEN MEDICATIONS AND ANTIBIOTICS SINCE ONSET OF EVENT. OVER THE COURSE OF THE FOLLOW-UP VISITS, PATIENT SYMPTOMS OF PAIN, LIGHT SENSITIVITY, VISUAL ACUITY, INTRAOCULAR PRESSURE AND PSEUDOMONAS CORNEAL ULCER OS WERE REPORTED. SYMPTOMS AND SIZE OF ULCER FLUCTUATED BETWEEN IMPROVING AND WORSENING. AT LAST FOLLOW-UP VISIT, THE PHYSICIAN RECOMMENDED AN NSAID PRESCRIPTION. PATIENT WAS DIRECTED TO CONTINUE VIGAMOX. COOPERVISION FOLLOW-UP WITH PHYSICIAN ON (B)(4) 2013. IT WAS NOTED: PATIENT DISCONTINUED LENS WEAR, WHITE CORNEAL OPACITY TEMPORALLY IN THE LEFT EYE, CORNEAL SCAR IS STABLE AND PSEUDOMONAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38319 BIOFINITY SPHERE COMFILCON A LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED 6137552159

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S