BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON-A

    MDR report key: 1915678 · Received December 1, 2010

    Report

    Report Number
    1033553-2010-00150
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 1, 2010
    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

    DEVICE NOT RETURNED. NO EVAL 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 THE PT DEVELOPED A CORNEAL ULCER WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A LENSES ARE NOT MARKETED IN THE US. THE PT REPORTED PURCHASING CONTACT LENSES (CL) ABOUT 6 MONTHS PRIOR TO CONTACTING OUR FIRM. THE PT REPORTEDLY HAD PAIN IN THE LEFT EYE (OS) FOLLOWING ABOUT 1 MONTH CL WEAR. THE PT WENT TO AN EMERGENCY ROOM AT (B)(6) HOSPITAL AT NIGHT COMPLAINING OF "UNBEARABLE PAIN." THE PT WAS REPORTEDLY DIAGNOSED WITH A CORNEAL ULCER. THE PT SAID HE/SHE RECEIVED OUTPATIENT TREATMENT FOR ABOUT 2 WEEKS, WAS PRESCRIBED "5 OR 6 KINDS OF EYE DROPS," WORE AN EYE PATCH FOR ABOUT A MONTH AND WAS INSTRUCTED TO DISCONTINUE CL WEAR. THE PT SAID THAT THE TREATMENT WAS COMPLETED ON (B)(6) 2010. ON (B)(6) 2010, (B)(6) HOSPITAL WAS CONTACTED FOR INFO, THEY REQUIRED A WRITTEN CONSENT FROM THE PT TO RELEASE INFO. THE PT WAS CONTACTED AND A CONSENT FORM WAS MAILED TO THE PT. AT THAT TIME, THE PT ADDED THAT THE PT HAD A CORNEAL SCAR AND "SEES SOMETHING LIKE A PILLAR OF LIGHT AND SLIGHTLY HAS DIFFICULTY SEEING." A SIGNED CONSENT FORM HAS NOT BEEN RECEIVED. ON (B)(4) 2010, THE PT WAS CALLED ABOUT THE CONSENT FORM; THE PT SAID HE/SHE WOULD SEND THE CONSENT FORM ON HIS/HER FIRST DAY OFF. THE PT'S LENSES HAVE NOT BEEN RECEIVED FOR EVAL. WE RECEIVED THE LOT NUMBER AND A LOT HISTORY REVIEW REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. SUBSEQUENT TO THE RELEASE OF THIS LOT, IT WAS DISCOVERED THAT AN ISOLATED ISSUE IN ONE PORTION OF THE LENS RINSING PROCESS IMPACTED SOME PRODUCT FROM THE MANUFACTURING LINE WHICH PRODUCED THIS LOT. AT THE TIME OF PRODUCT RELEASE, ALL DOCUMENTATION SHOWED THAT THIS LOT MET ALL RELEASE CRITERIA. AS A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS INJURY AND DETAILS OF LOCATION, SIZE, VISUAL ACUITY OR CONFIRMATION BY A MEDICAL PROFESSIONAL WERE NOT AVAILABLE, THIS EVENT IS BEING REPORTED AS WORST CASE. IF ADDITIONAL INFO IS RECEIVED, WE WILL REPORT IT 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 1-DAY ACUVUE TRUEYE NARAFILCON-A SOFT CONTACT LENS LPL VISTAKON NA 4923320104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R