BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENSES

    MDR report key: 1624952 · Received March 5, 2010

    Report

    Report Number
    1033553-2010-00015
    Event Type
    Injury
    Date Received
    March 5, 2010
    Report Date
    March 5, 2010
    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. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON 09 FEBRUARY 2010, THE J&J VISTAKON, (B) (4) AFFILIATE, REPORTED A LITERATURE SEARCH FOUND A RETROSPECTIVE STUDY PUBLISHED BY DR. YASUHISA ISHIBASHI TITLED "RECENT INCREASE OF ACANTHAMOEBA KERATITIS IN (B) (6)," WHICH WAS PUBLISHED IN (B) (6) 2010, VOLUME 3, NO.1, PP.22-29 TABLE 1, PG. 24. THIRTY REPORTED CASES OF ACANTHAMOEBA, DOCUMENTED IN (B) (6) LITERATURE, WERE EXAMINED FROM 1988 TO 2008. THE STUDY COMPARED 37 CASES EXPERIENCED FROM 1988 TO 2001 AND 30 CASES FROM 2002 AND 2008, SIX OF THE THIRTY CASES STUDIED BETWEEN 2002 AND 2008, WORE "ACUVUE" LENSES; ONE OF THE SIX CASES REPORTED WAS A BILATERAL EVENT. DR. (B) (6) WAS CONTACTED; HE INDICATED THAT THE PATIENTS WEARING "ACUVUE" PRODUCT WERE WEARING ACUVUE 2 BRAND CONTACT LENSES. THE PRODUCT AND LOT NUMBER WERE NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. BASED ON THE LIMITED INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. THIS MEDWATCH FORM IS TO DOCUMENT ONE OF THE SIX CASES: CASE NUMBER: (B) (6). PT'S INITIALS: (B) (6). AFFECTED EYE: OS. TYPE OF CL: DAILY WEAR, 2-WEEK REPLACEMENT LENS. INITIAL DISEASE STAGE: INITIAL STAGE. PT'S VA AT THE INITIAL VISIT: 0.5 (20/40). PT'S VA AT THE FINAL VISIT: 1.2 (20/20). IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. ALL MDR REPORTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R