BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLORBLENDS

    MDR report key: 4810456 · Received June 2, 2015

    Report

    Report Number
    9681121-2015-00506
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    August 18, 2015
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P830037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE OF LOT # 31146529 WAS PROVIDED AS 12/15/2014. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RESOLUTION OF THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO ADVERSE COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS KNOWN AND THREE COMPLAINT SAMPLES WERE RETURNED FOR EVALUATION. THE COMPLAINT SAMPLES WERE FOUND TO MEET MANUFACTURING SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THREE MED WATCH REPORTS HAVE BEEN REPORTED IN THIS COMPLAINT INCIDENT (INTERNAL REFERENCE # (B)(4)). THREE REPORTS ARE REQUIRED DUE TO BOTH EYES BEING AFFECTED AND THE INABILITY TO DETERMINE WHICH OF THE REPORTED LOTS WERE FOR WHICH EYE. THE MED WATCH REPORTS HAVE BEEN DISTINGUISHED BY THE LOT. REPORT # 1 WAS IN REFERENCE TO THE REPORTED LOT # 31148211. REPORT # 2 IS IN REFERENCE TO THE REPORTED LOT # 31146529. REPORT # 3 IS IN REFERENCE TO THE REPORTED UNKNOWN LOT. AS OF (B)(6) 2015, THE CONSUMER REPORTED THAT SHE HAD RESUMED CONTACT LENS WEAR ON (B)(6) 2015 AND SHE HAS HAD NO ISSUES AS OF YET.

    Description of Event or Problem · 1

    THREE MED WATCH REPORTS HAVE BEEN REPORTED IN THIS COMPLAINT INCIDENT (INTERNAL REFERENCE (B)(4)). THREE REPORTS ARE REQUIRED DUE TO BOTH EYES BEING AFFECTED AND THE INABILITY TO DETERMINE WHICH OF THE REPORTED LOTS WERE FOR WHICH EYE. THE MED WATCH REPORTS HAVE BEEN DISTINGUISHED BY THE LOT. REPORT # 1 WAS IN REFERENCE TO THE REPORTED LOT # 31148211. REPORT # 2 IS IN REFERENCE TO THE REPORTED LOT # 31146529. REPORT # 3 IS IN REFERENCE TO THE REPORTED UNKNOWN LOT. A REPORT RECEIVED ON 05/04/2015 FROM A FEMALE CONSUMER STATING SHE CAUGHT AN INFECTION AFTER REFILLING HER PRESCRIPTIONS AND INSERTING LENS. THE INFECTION WAS CLEAR AND SHE REINSERTED A NEW LENS FROM THE SAME LOT AND THE INFECTION REAPPEARED FOR A SECOND TIME. THE INFECTION CLEARED UP AND SHE REINSERTED A NEW LENS FROM SAME LOT NUMBER AGAIN AND HER EYES BECAME RE INFECTED. AS OF (B)(6) 2015 THE CONSUMER REPORTED THE TREATING PHYSICIAN'S DIAGNOSIS AS AN EXPOSURE TO KERATO-CONJUNCTIVITIS, BLEPHARITIS, CENTRAL CORNEAL ULCER AND PINGUECULA, SUPERFICIAL INJURY OF CORNEA, MARGINAL CORNEAL ULCER, AND KERATITIS AND TEARS FILM INSUFFICIENCY. THE CONSUMER SOUGHT MEDICAL ATTENTION ON THE FOLLOWING DATES IN (B)(6): (B)(6) 2015. CONSUMER SOUGHT MEDICAL ATTENTION AGAIN IN (B)(6) ON THE FOLLOWING DATES: (B)(6) 2015. THE TREATMENT PRESCRIBED INCLUDED ARTIFICIAL TEARS EVERY HOUR, ERYTHROMYCIN AT BEDTIME, OFLOXACIN EVERY HOUR THEN EVERY FOUR HOURS AND A LUBRICATING EYE DROP EVERY HOUR. THE CONSUMER REMOVED THE LENSES AT THE FIRST INDICATION OF DISCOMFORT OR PAIN. THE ISSUE RESOLVED WHEN THE CONSUMER DISCONTINUES LENS WEAR. CONSUMER DISCONTINUED CONTACT LENS WEAR ON (B)(6) 2015. THE SYMPTOMS REAPPEAR IF THE CONSUMER INSERTS A FRESH PAIR FROM THE SAME BOXES. SHE DID NOT NOTICE ANY DEPOSITS ON THE LENSES AND ADMITTED TO SLEEPING IN HER CONTACTS ON (B)(6) 2015. THE LENSES SOAKED IN SOLUTION ANYWHERE FROM 10 HOURS TO 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356388 FRESHLOOK COLORBLENDS EXTENDED WEAR SOFT CONTACT LENS LPM PT. CIBA VISION BATAM NA 31146529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention