BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 2912869 · Received January 9, 2013

    Report

    Report Number
    9681121-2012-00040
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVAL. THE MFG REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MFG PROCESS. NO COMPLAINT OR MFG TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A REPORT OF A CENTRAL CORNEAL ULCER ASSOCIATED WITH THE LENS WEAR WAS RECEIVED FROM AN EYE CARE PROFESSIONAL. A PT WHO IS KNOWN TO OVER WEAR LENSES PAST THE RECOMMENDED REPLACEMENT SCHEDULE, CONTINUED TO WEAR LENSES ONCE THEY BEGAN TO BOTHER THE EYE. THE LENS WAS WORN AS EXTENDED WEAR. THE PT SOUGHT MEDICAL ATTENTION AND THE LENS WAS REMOVED BY THE EYE CARE PROFESSIONAL. A CENTRAL CORNEAL ULCER WITH POSSIBLE PERMANENT VISION LOSS FROM SCARRING WAS DIAGNOSED IN THE LEFT EYE. CILOXAN, VIGAMOX, AND ERYTHROMIACIN OINTMENT WERE PRESCRIBED AND F/U WAS SCHEDULED FOR THE NEXT DAY. THE FOLLOWING DAY, THE PT WAS REFERRED TO AN OPHTHALMOLOGIST. THE ULCER WAS DESCRIBED AS "LOOKING BAD" AND HAZE WAS OBSERVED ON THE STROMA. ADDITIONAL INFO RECEIVED FROM THE SPECIALIST'S EXAM THAT OCCURRED ON (B)(6) 2012, INDICATES THE PT PRESENTED TO THE OFFICE WITH SEVERE PAIN, MODERATE REDNESS, WATERY DISCHARGE, AND PHOTOPHOBIA. THE INITIAL MEDICATION PRESCRIBED FOR THE PT WAS VIGAMOX OINTMENT TO BE USED EVERY FIFTEEN MINUTES FOR THE FIRST FOUR HRS, TAPERING TO EVERY HR. LUBIFRESH (REWETTING) OINTMENT WAS RECOMMENDED FOR USE EVERY HR. THE SPECIALIST DESCRIBED THE ULCER AS NEUTROPIC, 1.6 MILLIMETER IN SIZE, AND LOCATED PARACENTRALLY. WIDE TO MEDIUM INFILTRATES, DIFFUSED WITHIN THE STROMA, CORNEAL EDEMA, AND FOLDS IN DESCEMENT'S MEMBRANE WERE OBSERVED. THE INFILTRATES WERE LOCATED IN THE TEMPORAL TO CENTRAL REGION OF THE CORNEA. CELLS WERE NOT OBSERVED IN THE ANTERIOR CHAMBER AND THE VISION WAS NOTATED AT COUNTING FINGERS WITHOUT CORRECTION. THE PT WAS ADVISED TO DISCONTINUE EXTENDED WEAR AND TO NOT RUB THE EYE. CORNEAL EROSION WAS DISCUSSED AND THE PT WAS ADVISED TO KEEP THE EYE CLOSED. THE PT WAS ADVISED TO CONTINUE THE ERYTHROMYCIN OINTMENT, THE VIGAMOX OINTMENT EVERY TWO HRS AND THE LUBIFRESH EVERY HR. ADDITIONAL INFO RECEIVED FROM THE QUESTIONNAIRE COMPLETED BY THE REFERRING DOCTOR ON (B)(6) 2012, INDICATES THE ULCER WAS LOCATED IN THE CENTRAL ZONE (FOUR TO SIX MILLIMETERS) OF THE CORNEA AND HAD DECREASED TO LESS THAN ONE MILLIMETER IN SIZE. THREE INFILTRATES, ALSO LOCATED CENTRALLY, WERE OBSERVED. THE LARGEST INFILTRATE WAS 2.5 MILLIMETERS. THE PRESCRIBED TREATMENT AND DOSAGE WAS VIGAMOX OINTMENT EVERY THREE HRS AND PRED FORTE EVERY FOUR HRS. MODERATE STAINING IN THE CORNEA WAS OBSERVED. THE PT WAS SCHEDULED FOR F/U ON (B)(6) 2012. ANOTHER QUESTIONNAIRE, COMPLETED BY THE REFERRING EYE CARE PROFESSIONAL, WAS COMPLETED AND RECEIVED ON (B)(6) 2012. THE NEW QUESTIONNAIRE PROVIDED INFO THAT THE DISCHARGE WAS MUCOPURULENT INSTEAD OF WATERY. ADDITIONAL INFO RECEIVED ON (B)(6) 2013 FROM THE REFERRING EYE CARE PROFESSIONAL'S OFFICE, INDICATES THE ULCER HAS RESOLVED; HOWEVER, LENS WEAR HAS NOT RESUMED DUE TO SCARRING ON THE CORNEA. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12858 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBA VISION BATAM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention