BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR PLUS

    MDR report key: 1211051 · Received October 24, 2008

    Report

    Report Number
    1033553-2008-00121
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IN 2008, AN EYE CARE PROFESSIONAL (ECP) CONTACTED VISTAKON WITH A QUESTION ABOUT CONTACT LENSES (CL) AND STATED THAT A PT REPORTED AN EYE INFECTION WHILE WEARING ACUVUE OASYS CL. THE PT WAS TREATED BY AN UNKNOWN DOCTOR. THE PT'S EYE(S) WERE FINE AT THE TIME. THE PT WAS WEARING AS EXTENDED WEAR; THE REPLACEMENT SCHEDULE IS UNKNOWN. VISTAKON HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING ECP. THE REPORTING ECP STATED THAT HE/SHE DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE EVENT OR THE TREATING DOCTOR. NO ADDITIONAL INFORMATION IS EXPECTED. THE PT HAS BEEN PLACED IN A DIFFERENT PRODUCT. A LOT NUMBER FOR THE PRODUCT IN QUESTION WAS NOT AVAILABLE. THE PRODUCT IN QUESTION WAS NOT AVAILABLE FOR EVALUATION. MDR EVENTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other