BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS

    MDR report key: 2181098 · Received July 22, 2011

    Report

    Report Number
    1033553-2011-00050
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT REPORTED ON A (B)(6) SOCIAL MEDIA SITE THAT THEY HAD SWITCHED FROM ACUVUE2 TO ACUVUE OASYS BRAND CONTACT LENSES AND THAT THE LENSES "HAVE GIVEN ME INFECTIONS CONSTANTLY. I HAVE HAD PINK EYE AND ULCERS EVER SINCE I STARTED WEARING THESE A FEW MONTHS AGO." MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CONSUMER BUT NO RESPONSE HAS BEEN RECEIVED. NO LOT INFO WAS PROVIDED AND PRODUCT IS NOT AVAILABLE FOR EVAL. THIS EVENT HAS BEEN DETERMINED TO BE A SERIOUS INJURY BASED ON REPORT OF "INFECTIONS" AND "ULCERS" WHILE WEARING LENSES. "CORNEAL ULCER" OR "INFECTIONS" MAY OR MAY NOT BE A SERIOUS INJURY. BASED ON THE LIMITED INFO RECEIVED, THIS COMPLAINT WILL BE REPORTED AS A SERIOUS INJURY AS WORST CASE. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MGMT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS BRAND WITH HYDRACLEAR PLUS DISPOSABLE SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other