BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2

    MDR report key: 7176334 · Received January 9, 2018

    Report

    Report Number
    9617710-2018-05004
    Event Type
    Injury
    Date Received
    January 9, 2018
    Report Date
    December 15, 2017
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT (PT) FROM (B)(6) CALLED TO REPORT WHILE WEARING THE ACUVUE2 BRAND CONTACT LENSES HE/SHE FELT DISCOMFORT AND REMOVED THE SUSPECT LEFT EYE CONTACT LENS AND FOUND IT WAS ¿BROKEN IN PIECES¿. THE PT WENT TO THE OPHTHALMOLOGIST AND WAS DIAGNOSED WITH A CORNEAL ULCER. THE EVENT OCCURRED IN (B)(6) 2017 AND THE PT WAS UNABLE TO WEAR CONTACT LENSES FOR ¿ABOUT A MONTH¿. PT REPORTED ALL THE LEFT EYE LENSES HAVE BEEN ¿BREAKING IN PIECES¿. ON (B)(6) 2017 A CALL WAS PLACED TO THE PT FOR ADDITIONAL MEDICAL AND PRODUCT INFORMATION, BUT THE TELEPHONE NUMBER PROVIDED WAS NOT IN SERVICE. ON (B)(6) 2017 THE PT CALLED AND VERIFIED THE TELEPHONE NUMBER. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2017 AN EMAIL WAS RECEIVED FROM THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: PT REPORTED ¿5 DAYS AGO I USED THE LAST LENS OF THE BOX IN QUESTION AND TODAY I FOUND IT BROKEN.¿ NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2017 AND (B)(6) 2018 ADDITIONAL TELEPHONE CALLS WERE PLACED TO THE PT FOR ADDITIONAL INFORMATION, BUT NO RETURN CALLS FROM THE PT HAVE BEEN RETURNED. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. IT IS UNKNOWN IF THE SUSPECT PRODUCT IS AVAILABLE FOR RETURN. 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 L002Z8S WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17950 ACUVUE 2 LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK NA L002Z8S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R