BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE DAY ACUVUE TRUEYE

    MDR report key: 1910550 · Received November 19, 2010

    Report

    Report Number
    1033553-2010-00141
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6) AFFILIATE. THIS INFORMATION INDICATES A PATIENT WAS WEARING 1 DAY TRU-EYE ACUVUE CONTACT LENSES (CL) AND DEVELOPED A CORNEAL ULCER OD. THE DATE THE EVENT OCCURRED IS UNKNOWN AT PRESENT. ON (B)(6) 2010 THE PT REPORTED THE INCIDENT TO OUR AFFILIATE. "THE PT DIDN'T REMEMBER THE EXACT DATE AND DETAILS." THE PT REPORTED HAVING WORN A CL AND ON REMOVING THAT EVENING, HE/SHE EXPERIENCED "UNBEARABLE PAIN". THE PT SAW AN EYE CARE PROFESSIONAL (ECP) THE NEXT DAY AND WAS DIAGNOSED WITH A CORNEAL ULCER. THE TREATMENT REGIMEN INCLUDED "TWO KINDS OF ANTIBIOTIC EYE DROPS, ONE EYE OINTMENT." THE PT STATED THAT "THE SYMPTOM RESOLVED AT THE MOMENT" HE/SHE CONTACTED OUR FIRM. A LOT HISTORY REVIEW AND PRODUCT EVALUATION WERE NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED AND SUSPECT PRODUCT WAS NOT AVAILABLE FOR EVALUATION. "CORNEAL ULCER" MAY OR MAY NOT BE A SERIOUS INJURY. BASED ON THE LIMITED INFORMATION RECEIVED, THIS INJURY WILL BE REPORTED AS A SERIOUS INJURY AS A WORST CASE. IF ADDITIONAL INFORMATION 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 ONE DAY ACUVUE TRUEYE SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention