BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 1-DAY TRUEYE NARAFILCON A

    MDR report key: 1940845 · Received December 23, 2010

    Report

    Report Number
    1033553-2010-00166
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 23, 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

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

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE REPORTED THAT IN LATE OCTOBER, A PATIENT PRESENTED TO A LOCAL EYE CLINIC AND WAS DIAGNOSED WITH A CORNEAL EPITHELIAL EROSION. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2010 AND DIAGNOSED WITH A CORNEAL ULCER OS. THE LARGE, "THREADLIKE" ULCER LOCATED AT 2 O'CLOCK POSITION, MIDPERIPHERALLY IS SUSPECTED TO BE INFECTIOUS. THE PATIENT WAS PRESCRIBED GATIFLO, FLAVITAN AND HYALEIN EYE DROPS AND CRAVIT 500MG PO FOR 3 DAYS. BY (B)(6) 2010, THE ULCER RESOLVED AND THE PATIENT RELEASED TO RESUME LENS WEAR. THE PATIENT HAD NO LOSS OF VISUAL ACUITY. IN CONJUNCTION WITH THE AUGUST 18, 2010 VOLUNTARY RECALL, VISION CARE CONDUCTED A DETAILED TECHNICAL REVIEW OF THE MANUFACTURING PROCESS WHICH DETERMINED THAT THE INCOMPLETE RINSING OF PRODUCT IDENTIFIED IN THE RECALL WAS CORRECTED BY A MAINTENANCE REPLACEMENT OF THE RINSING DOSE HEAD. THE REVIEW ALSO REVEALED ADDITIONAL SOURCES OF PROCESS VARIATION NOT PREVIOUSLY IDENTIFIED. IN PARALLEL TO THE TECHNICAL REVIEW, A DUE DILIGENCE STATISTICALLY-BASED SAMPLING PROTOCOL WAS INITIATED TO RETROSPECTIVELY ASSESS DECANOIC ACID LEVELS IN PRODUCT FROM ALL LINES CURRENTLY MANUFACTURING 1-DAY ACUVUE TRUEYE (NARAFILCON A). THE TESTING REVEALED A HIGHER THAN EXPECTED LEVEL OF VARIATION IN THE MANUFACTURING PROCESS AND CONFIRMED THAT ISOLATED LENSES PRODUCED IN (B)(4) AFTER MARCH 3 AND (B)(4) MAY CONTAIN LEVELS OF DECANOIC ACID ABOVE THE ESTABLISHED LIMIT. AS A RESULT, EFFECTIVE OCTOBER 22, 2010, THE RECALL WAS EXPANDED TO INCLUDE ALL 1-DAY ACUVUE TRUEYE (NARAFILCON A) LOTS MANUFACTURED IN (B)(4). THIS REPRESENTS A MANUFACTURING TIME FRAME FROM MID-MARCH THROUGH MID-AUGUST 2010. LOT HISTORY HAS BEEN REQUESTED AND WILL BE REPORTED IN A FOLLOW UP. IF ADDITIONAL INFORMATION IS RECEIVED, 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 ACUVUE 1-DAY TRUEYE NARAFILCON A DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA 5021440408

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other