BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1869522 · Received October 6, 2010

    Report

    Report Number
    1033553-2010-00097
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    August 3, 2010
    Report Date
    October 6, 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

    EVALUATION: METHOD: DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT REPORTED PAIN OU WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES NARAFILCON A (NARAFILCON A LENSES ARE NOT MARKETED IN THE U.S.). THE PT REPORTED HE/SHE VISITED AN EYE CARE PROFESSIONAL (ECP) AND WAS DIAGNOSED WITH KERATITIS. THE SHOP WHERE THE PT PURCHASE THE LENSES WAS CONTACTED ON 09/10/2010 AND TOLD US THAT THE PT CONTACTED THEM ON 08/18/2010 AND SAID HE/SHE COULD NOT SEE ANYTHING WITH RIGHT EYE AND THE PT HAD CONSULTED AN ECP. ON 09/21/2010, THE CLINIC WHERE THE PT WAS TREATED WAS CONTACTED AND AN OFFICE CLERK PROVIDED THE FOLLOWING INFORMATION: THE PT WAS NOT PRESCRIBED 1-DAY ACUVUE TRUEYE LENSES AT THAT CLINIC. THE PT WAS SEEN ON (B)(6) 2010 AND WAS DIAGNOSED WITH KERATITIS OD. THE PT WAS TREATED WITH GATIFLO, NIFLAN, SANTEMYCIN, AND HYALEIN EYE DROPS. THE PT WAS INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR. ON (B)(6) 2010, THE PT WAS INSTRUCTED TO RETURN TO THE CLINIC IF THE PT HAD ANY FURTHER ISSUES WITH THE OD. WE REQUESTED INFORMATION REGARDING THE SERIOUSNESS OF THIS EVENT AND IF THERE WAS A CAUSAL RELATIONSHIP WITH THE CONTACT LENSES. THE OFFICE CLERK WOULD PROVIDE NO ADDITIONAL INFORMATION WITHOUT WRITTEN CONSENT FROM THE PT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THE PRODUCT WAS REQUESTED FOR EVALUATION AND IS EXPECTED TO BE RETURNED. KERATITIS MAY OR MAY NOT BE A SERIOUS INJURY, BASED UPON THE AVAILABLE INFORMATION; THIS EVENT IS BEING REPORTED AS A WORST CASE. IF ADDITIONAL INFORMATION IS REC'D, 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 NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other