BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 2050999 · Received April 4, 2011

    Report

    Report Number
    1033553-2011-00027
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT CONTACTED OUR FIRM BY EMAIL STATING "AFTER USING THE LENSES, DEVELOPED ULCERS ON CORNEA. SIX MONTHS LATER TRIED LENSES AGAIN AND DEVELOPED EYE IRRITATION. DISCONTINUED USE." THE PT HAS NOT RESPONDED TO NUMEROUS ATTEMPTS TO CONTACT BY PHONE AND EMAIL. THE PT PROVIDED EYE CARE PROVIDER'S INFO BUT THAT OFFICE DENIED KNOWLEDGE OF THE PT. "CORNEAL ULCER" MAY OR MAY NOT BE A SERIOUS INJURY. BASED ON THE LIMITED INFO RECEIVED, THIS INJURY WILL BE REPORTED AS A SERIOUS INJURY AS A WORST CASE. A DEVICE HISTORY REVIEW WAS PERFORMED: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. NO QUALITY EVENTS ASSOCIATED WITH THIS LOT. THE LOT HISTORY REVIEW INDICATED LOT B0097ZS WAS MFR UNDER NORMAL CONDITIONS. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS DISPOSABLE SOFT CONTACT LENS LPM VISTAKON NA B0097ZS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other