BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2 OPTIX

    MDR report key: 3961812 · Received June 19, 2014

    Report

    Report Number
    9681121-2014-00041
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING DEVICE HISTORY RECORD HAS BEEN CONDUCTED AND CONFIRMED THAT LOT 31057125 MET THE IN-PROCESS AND FINISHED PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. THE IN-PROCESS PACKAGE INTEGRITY TEST CONFIRMED TO MEET SPECIFICATIONS. THE MICROBIOLOGICAL EVALUATION OF SALINE SYSTEM AND WATER SYSTEM; STERILIZATION AND BI INCUBATION RESULTS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. NO INDICATION OF MANUFACTURING ERROR THAT COULD LEAD TO THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A REPORT OF A CORNEAL ULCER WAS RECEIVED FROM A PT ON (B)(6) 2014, SHE FELT PAIN AND DISCOMFORT IN HER EYES. WHEN SHE REMOVED THE LENSES, SHE PRESENTED WITH IRRITATION, SENSITIVITY TO LIGHT, AND SHE WAS UNABLE TO OPEN HER EYES. SHE SOUGHT MEDICAL ATTENTION TWICE, DUE TO THE CORNEAL ULCER. PT STATED SHE IS USING ANTIBIOTICS AND EYE DROPS FOR TREATMENT. PT WAS PRESCRIBED VIGAMOX: 1 DROP EVERY HOUR AND 1 DROP EVERY 2 HOURS AFTER (B)(6) 2014. SYSTANE: 1 DROP EVERY 2 HOURS STARTING (B)(6) 2014. ALSO THE PT CONTINUES TREATMENT EVERY 2 DAYS. ON (B)(6) 2014, ADDITIONAL INFO WAS RECEIVED FROM THE ECP INDICATING THE CONSUMER WAS DIAGNOSED WITH A CORNEAL ULCER ON THE RIGHT EYE AND WAS HOSPITALIZED. PATIENT WORE THE LENS FOR 15 DAYS, SHE DOES NOT HAVE ANY PRE-EXISTING OCULAR OR MEDICAL HISTORY. NO BIOPSY OR CULTURE SCAPING PERFORMED. PT WAS TREATED WITH VIGAMOX (PER HOUR), AND LATER PER 2 HOURS FOR 15 DAYS. PT HAS NOT RESUMED LENS WEAR; SHE WILL BE REFIT IN TO A RIGID LENS. PT EXPERIENCED SEVERE PAIN ND REDNESS WITH A MUCOPURULENT DISCHARGE. PT HAD A SEVERE ANTERIOR CHAMBER REACTION IN THE PERIPHERAL AT 1.5 X 1.5 MM. THERE WAS ONE INFILTRATE PRESENT WITH CORNEAL STAINING OF GREATER THAN 50% WITH PERMANENT SCARRING. THE EVENT HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360911 O2 OPTIX LENSES, SOFT CONTACTS, EXTENDED WEAR LPM PT CIBA VISION BATAM 31057125

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O