BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1940707 · Received December 22, 2010

    Report

    Report Number
    1033553-2010-00163
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 22, 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

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED FROM OUR (B)(4) AFFILIATE. ON (B)(6) 2010, A PT (PT) REPORTED A MEDICAL CLAIM TO OUR FIRM WHILE WEARING 1-DAY ACUVUE TRUEYE (NARAFILCON A). NARAFILCON A LENSES ARE NOT MARKETED IN THE US. THE PT REPORTED THAT THE PT'S "CORNEA CAME OFF". THE PT SAW AN ECP ON (B)(6) 2010 AND WAS DIAGNOSED WITH A CORNEAL ULCER OD. THE PT WAS TREATED WITH CRAVIT, HYALINE OINTMENT AND INSTRUCTED TO RETURN ON (B)(6) 2010. ON (B)(6) 2010, WE CONTACTED THE PT WHO STATED THAT HE/SHE WAS TOLD TO NOT WEAR CONTACT LENSES (CL) UNTIL THE ULCER RESOLVED; MEDICATIONS WERE CONTINUED. THE PT CONTACTED AN ECP ABOUT RESUMING CL WEAR AS SOON AS POSSIBLE "AS WEARING EYE GLASSES IS NOT PRACTICAL". THE PT WAS TOLD "TO WEAR 1 DAY ACUVUE MOIST FOR SHORT TIME AND IF THERE WILL NO PROBLEM, WEAR 1 DAY TRUEYE THE FOLLOWING DAY." ON (B)(6) 2010, OUR FIRM CONTACTED THE TREATING EYE CLINIC AND WAS TOLD THAT THEY PRESCRIBED 1 DAY ACUVUE MOIST LENSES, THE PT "PURCHASED 1 DAY TRUEYE ON RECOMMENDATION OF CL SALES SHOP". THE PT'S WRITTEN CONSENT WAS NEEDED BEFORE THEY COULD PROVIDE ANY ADD'L INFO. ON 12/2010, WE CONTACTED THE PT WHO STATED THAT HE/SHE WAS EXPERIENCING "MILD PAIN", "EYE DROPS" CONTINUED. THE PT WAS SCHEDULED TO RETURN TO THE CLINIC ON (B)(6) 2010. NO ADD'L INFO HAS BEEN RECEIVED. OUR FIRM WILL CONTINUE TO MAKE ATTEMPTS TO COLLECT ADD'L INFO. WE HAVE REQUESTED THE PT'S WRITTEN CONSENT FOR MEDICAL RELEASE OF INFO. THE TRUE SERIOUSNESS OF THIS EVENT IS UNCONFIRMED. THIS EVENT IS BEING REPORTED AS WORST CASE. THREE SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE PH MEASURED WITHIN SPEC. THERE WAS NOT ENOUGH SOLUTION TO MEASURE CONDUCTIVITY. A BATCH RECORD REVIEW WAS PERFORMED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS WERE WITHIN SPEC. PRIMARY & SECONDARY PACKAGING AUDITS RESULTED IN ZERO DEFECTS. ALL PACKAGES TESTED, MET SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT # 5311390307 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY EXECUTIVE MGMT 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 5311390307

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention