BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND W/HYDRACLEAR PLUS

    MDR report key: 2780497 · Received October 5, 2012

    Report

    Report Number
    1033553-2012-00052
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 5, 2012
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    A PATIENT ( PT) CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2012 STATING HER EYES HURT, HER CONTACT LENSES (CL) WERE FOGGY, AND SHE WAS NOT ABLE TO SEE "CLEARLY". THE PATIENT WAS WEARING ACUVUE OASYS CL WHEN THE EVENT OCCURRED. THE REPORT FOR THE OTHER EYE IN MDR #1033553-2012-00053. THE PATIENT WAS WEARING AS DAILY WEAR AND REPLACED THEM IN LESS THAN 2 WEEKS. THE DISINFECTING SOLUTION WAS NOT REPORTED. THE PATIENT CONSULTED HER PRIMARY ECP ON (B)(6) 2012 AND WAS DIAGNOSED WITH AN "INFECTION, ULCER IN ONE EYE, AND DAMAGE TO THE CORNEA", CL WEAR DISCONTINUED. THE EYE IN WHICH THE PATIENT EXPERIENCED THE ULCER COULD NOT BE CONFIRMED. THE TREATMENT REGIMEN INCLUDED VIGAMOX EYE DROPS Q1HR. THE PATIENT WANTED A SECOND OPINION AND SAW ANOTHER ECP WHO TOLD HER SHE "HAD AN EYE INFECTION IN BOTH EYES, AND THAT THE CORNEA'S WERE DAMAGED". THE PATIENT WAS INSTRUCTED NOT TO WEAR CL. THE PATIENT STATED "I WAS 3/4 BLIND". SHE SAID HER EYES ARE MUCH BETTER COMPARED TO A COUPLE OF WEEKS AGO AND THE INFECTION HAS RESOLVED. OUR FIRM HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO OBTAIN CLINICAL INFORMATION FROM THE DOCTOR WHOM THE PATIENT SOUGHT A SECOND OPINION. THE DOCTOR DECLINED PROVIDING CLINICAL INFORMATION DUE TO PATIENT PRIVACY ISSUES. THE PRIMARY ECP'S STAFF TOLD OUR FIRM THAT THE PATIENT PURCHASED OASYS FOR THE FIRST TIME ON (B)(6) 2012. ON (B)(6) 2012 THE ECP STATED THAT THE PATIENT WAS SEEN (B)(6) 2012 FOR DECREASED VISION. THE PATIENT WAS DX WITH "VERY SEVERE KERATITIS" AND TREATED WITH VIGAMOX Q1HR, ERYTHROMYCIN OINTMENT HS. THE PATIENT WAS TOLD SHE WOULD BE OUT OF CL FOR A LONG PERIOD OF TIME. THE PATIENT RETURNED ON (B)(6) 2012 STATING SHE FELT BETTER BUT HER VISION WAS UNCHANGED; VIGAMOX CONTINUED Q1HR. THE PATIENT DID NOT RETURN FOR HER 5 DAY FOLLOW-UP. THE ECP CALLED THE PATIENT ON (B)(6) 2012 INSTRUCTING HER TO START BION TEARS Q1HR AND DECREASE VIGAMOX TO Q 2-3 HRS. THE PATIENT WAS LAST SEEN ON (B)(6) 2012. SHE WAS INSTRUCTED TO CONTINUE TO BION TEARS, DISCONTINUE VIGAMOX AND START SYSTANE GEL. THE 12 SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF 10 CL WERE MEASURED AND A VISUAL INSPECTION PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS AND DIAMETER. ONE LENS HAD AN EDGE CHIP, NO OTHER VISUAL ATTRIBUTES OBSERVED. THE SOLUTION WAS TESTED; PH AND CONDUCTIVITY WERE IN SPECIFICATION. A DHR WAS PERFORMED; L001QDG PRODUCED UNDER NORMAL MANUFACTURING CONDITIONS. THE BATCH RECORD DID NOT SHOW ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION AND STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND W/HYDRACLEAR PLUS SOFT CONTACT LENS LPL VISTAKON NA L001QDG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R