BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS W/HYDRACLEAR

    MDR report key: 1021206 · Received March 28, 2008

    Report

    Report Number
    1033553-2008-00044
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    November 16, 2007
    Report Date
    March 28, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED 4 PTS WHO EXPERIENCED INFECTIOUS CORNEAL ULCER(S) (ICU). THE PTS EXPERIENCED A TOTAL OF 7 EVENTS. PT 1 EXPERIENCED 1 ULCER, PT 2 EXPERIENCED 3 ULCERS, PT 3 EXPERIENCED 2 ULCERS AND PT 4 EXPERIENCED 1 ULCER. THE DOCTOR REPORTED THAT IN EACH EVENT THE PT WAS INSTRUCTED TO D/C CONTACT LENSES (CL) UNTIL THE ULCER RESOLVED. IN EACH EVENT THE ULCER RESOLVED. PT 3 WORE ACUVUE OASYS CL AND WAS DIAGNOSED WITH ICU DURING 2 SEPARATE EVENTS. THIS RECORD HAS BEEN CREATED TO REPORT INFECTIOUS CORNEAL ULCER OD, DIAGNOSED IN 2007. IT IS UNKNOWN WHAT DISINFECTING SOLUTION THE PT WAS USING. THE TREATMENT REGIMEN INCLUDED D/C CL X 3WEEKS, VIGAMOX EVERY 15 MINUTES X6 THEN Q 30 MINUTES X6 THEN Q 3HRS. ECP REPORTED THAT THE ULCER RESOLVED. SEE MDR # 1033553-2008-000045 TO CAPTURE EVENT IN THE OTHER EYE. THE SUSPECT CL IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT AVAILABLE FOR DHR INVESTIGATION. THE MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS W/HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention