BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 2000991 · Received February 18, 2011

    Report

    Report Number
    1033553-2011-00014
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 19, 2010
    Report Date
    February 18, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CORNEAL OPACITY. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2010 TO REPORT REDNESS IN BOTH EYES (OU) WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A LENSES ARE NOT MARKETED IN THE US. THIS REPORT IS FOR THE LEFT EYE (OS). THE PT WAS PRESCRIBED "EYE DROPS" AND INSTRUCTED TO DISCONTINUE LENS WEAR. THE PT PROVIDED NO INFORMATION REGARDING PRESCRIBED MEDICATIONS OR THE EYE CARE PROFESSIONAL'S (ECP) OBJECTIVE FINDINGS. A CONSENT FORM TO REQUEST INFORMATION FROM THE ECP WAS SENT TO THE PT ON (B)(6) 2010. THE SIGNED CONSENT FORM WAS RECEIVED FROM THE PT AND OUR (B)(4) AFFILIATE CONTACTED THE ECP'S OFFICE FOR INFORMATION. ON (B)(6) 2011 WE RECEIVED A MEDICAL CERTIFICATE WITH THE FOLLOWING INFORMATION: THE PT WAS SEEN AT THE EYE CLINIC ON (B)(6) 2010 COMPLAINING OF PAIN, EYE TEARING AND DIFFICULTY SEEING OU. THE PT HAD 2+ OU BULBAR AND TARSAL CONJUNCTIVAL REDNESS. THE PT HAD SIGNIFICANT CORNEAL OPACITY CAUSED BY CORNEAL INFILTRATES "IN THE ALL LAYERS OF THE WHOLE CORNEA OU." "THE OPACITY SLIGHTLY IMPROVED WITH THE TREATMENT", BUT THE REPORT STATED THAT CONTINUING TREATMENT WILL BE NECESSARY. THE PT HAD PURCHASED 1 DAY ACUVUE TRUEYE LENSES ABOUT 2 MONTHS PRIOR TO THE VISIT. ON (B)(6) 2011 THE PT'S MOTHER PROVIDED ADDITIONAL INFORMATION, THE PT WAS INITIALLY INSTRUCTED TO RETURN FOR FOLLOW-UP EVERY DAY, BUT THE PT WAS SO BUSY AND COULD RETURN TO THE CLINIC ONLY ONCE A WEEK. THE PT IS CURRENTLY INSTRUCTED TO RETURN FOR FOLLOW-UP ONCE A MONTH. ON (B)(6) THE PT'S MOTHER REPORTED THAT THE PT WAS SEEN AT THE CLINIC ON (B)(6) 2011 AND WAS TOLD "THE PT WAS TOLD THAT THE PT WILL BE FINE AT ABOUT ONE MORE FOLLOW-UP VISIT." OUR (B)(4) AFFILIATE WILL TRY TO GET INFORMATION ABOUT THE PT'S RECOVERY. THE PRODUCT IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNK. IF ADDITIONAL INFORMATION IS RECEIVED, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE TRUEYE NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other