BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 CONTACT LENSES

    MDR report key: 1084348 · Received July 30, 2008

    Report

    Report Number
    1033553-2008-00081
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    May 5, 2008
    Report Date
    July 30, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED FROM MEMBERS OR OUR FOREIGN COUNTRY AFFILIATE WHO ATTENDED FOREIGN CONTACT LENS SOCIETY. THIS CASE OF OU CORNEAL ULCERS WAS PRESENTED BY AN EYE CARE PROFESSIONAL (ECP). THIS RECORD CAPTURES THE OS EVENT. IN 2006, THE PT DEVELOPED RED EYES. THREE DAYS LATER, THE PT SOUGHT TREATMENT AT A LOCAL EYE CLINIC AND WAS DIAGNOSED WITH INFECTIOUS KERATITIS, CELLS WERE OBSERVED IN THE ANTERIOR CHAMBER. VA 0.5 (20/40). THE PT WAS TREATED WITH GATIFLO, SULPELIN, TEARBALANCE AND BRONUCK. THE FOLLOWING MONTH, THE PT DEVELOPED CORNEAL ULCERS OU. THREE DAYS ALTER, THE PT WAS REFERRED TO AND VISITED THE HOSPITAL FOR TREATMENT. VA OS WITH CORRECTION 0.8 (20/25). PSEUDOMONAS SP. WAS CULTURED FROM THE LENS CASE AND LENS CARE SOLUTION. THE PT WAS TREATED AS AN OUTPATIENT DUE TO WORK SCHEDULE. TEN DAYS LATER, FLUMETHOLONE WAS ADDED TO THE TREATMENT REGIME. [AWAITING INFO FROM FOREIGN COUNTRY, REGARDING CHANGING OF MEDICATION FROM TOPICAL TO INTERNAL AGENT.] SIXTEEN DAYS LATER, PT WAS ADMITTED TO HOSPITAL DUE TO CORNEAL ULCERS OU, CILIARY INJECTION AND STROMAL INFILTRATION. TREATMENT: INTRAVENOUS FLUID- GATIFLO (FREQUENTLY), MODACIN 4G IN 10 DAYS), TIENAM AND PO CRAVIT. ON THE SAME DAY, PT WAS ADMITTED TO HOSPITAL DUE TO CORNEAL ULCERS OU, CILIARY INJECTION AND STROMAL INFILTRATION. TREATMENT: INTRAVENOUS FLUID- GATIFLO (FREQUENTLY), MODACIN (4G IN 10 DAYS), TIENAM AND PO CRAVIT. THE OS ULCER WAS 3.3MM X 2.9MM ON THE 4TH DAY OF HOSPITALIZATION AND 1.5MMX1.5MM ON THE 10TH DAY OF HOSPITALIZATION. THE PT WAS DISCHARGED THE FOLLOWING MONTH. THE PT'S BCVA OD 27 DAYS FOLLOWING DISCHARGE WAS 1.2 (20/15). BCVA OD 60 DAYS FOLLOWING DISCHARGE WAS 1.2 (20/15). THE PRESENTING ECP NOTED THE FOLLOWING: THE PT WAS USED MPS FOR LENS CARE: ROHTO C3 SOFT ONE MOIST (ROHTO PHARMACEUTICAL CO., LTD.). THE PT REPORTEDLY DID NOT RUB CONTACT LENSES. THE PT REPLACED SOLUTION ONCE A WEEK. THE PT DID NOT REPLACE THE LENS CASE AND DID NOT HAVE PERIODIC CHECKUPS. THE PT DID OBSERVE THE LENS REPLACEMENT CYCLE. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE 2 CONTACT LENSES SOFT CONTACT LENSES LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R