BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 DAY ACUVUE TRUEYE (NARAFILCON A)

    MDR report key: 2120193 · Received June 6, 2011

    Report

    Report Number
    1033553-2011-00035
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 6, 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

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE REPORTED THEY RECEIVED INFORMATION FROM A PT ON (B)(6) 2011. THE PT STATED THAT THE PT'S LEFT EYE (OS) CONDITION BECAME WORSE IN (B)(6). THE PT VISITED AN EYE CARE PROFESSIONAL (ECP) AT AN EYE CLINIC. THE DIAGNOSIS INFORMATION WAS PROVIDED BY THE PT AND WAS NOT VERIFIED WITH PT'S ECP AT THAT TIME. THE PT REPORTED BEING DIAGNOSED WITH "STAINING, REFRACTIVE INDEX ANGLE CHANGED DUE TO STAINING. GLARE AND PAIN OCCURRED AS A RESULT." THE PT WAS INSTRUCTED TO DISCONTINUE CONTACT LENS (CL) WEAR FOR "ABOUT A WEEK." THE PT WAS TREATED WITH CRAVIT AND BESTRON EYE DROPS. THE PT RETURNED TO THE CLINIC AND REPORTED THE PROBLEM HAD RESOLVED. OUR (B)(4) AFFILIATE REQUESTED AND RECEIVED AUTHORIZATION TO DISCUSS THIS EVENT WITH THE PT'S ECP. ON (B)(6) 2011, THE EYE CLINIC WAS CONTACTED AND THE FOLLOWING INFORMATION WAS RECEIVED. THE PT WAS INITIALLY SEEN ON (B)(6) 2011 DUE TO PAIN OS. DIAGNOSIS, "CORNEAL INFECTION OS" TREATMENT, CRAVIT & BESTRON EYE DROPS 5 TO 6 TIMES PER DAY. THERE WAS NO INSTRUCTION TO DISCONTINUE CL WEAR IN THE RECORD. THERE WAS NO INSTRUCTION FOR A RETURN VISIT. THE PT RETURNED TO THE CLINIC ON (B)(6) 2011 AND THE RECORD NOTED THAT THE CORNEAL INFECTION OS HAD RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE EYE CLINIC. AN ASSOCIATE FROM OUR (B)(4) AFFILIATE WILL VISIT THE CLINIC ON (B)(6) 2011 TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED CORNEAL INFECTION. THIRTEEN LENSES FROM THE SUSPECT LOT WERE RETURNED. THE PARAMETERS OF TEN 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 SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. A LOT HISTORY REVIEW WAS PERFORMED AND 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. LOT 5209150101 WAS PRODUCED UNDER NORMAL CONDITIONS. AS PART OF OUR ONGOING INVESTIGATION, RETURNED PRODUCT ASSOCIATED WITH THE EVENT WAS TESTED (B)(4). THE ACTUAL LENS ASSOCIATED WITH THE EVENT WAS NOT AVAILABLE FOR TESTING. THE RESULTS ARE AS FOLLOWS: ONE LENS OUT OF THE THREE SUPPLIED WAS ANALYZED (B)(4). 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 5209150101

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention