BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR

    MDR report key: 2161987 · Received July 11, 2011

    Report

    Report Number
    1033553-2011-00047
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY WAS COMPLETED AND INDICATED 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. BASED ON THE LIMITED INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. (B)(4). DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PATIENT WHO WORE ACUVUE OASYS CONTACT LENSES REPORTED EXPERIENCING AND BEING TREATED FOR A MEDICAL ADVERSE EVENT. THE PATIENT INITIALLY EXPERIENCED REDNESS AND SWELLING IN BOTH EYES (OU). THE PATIENT REMOVED THE LENS FROM THE LEFT EYE (OS), NOTED THE LENS WAS CHIPPED, DISCARDED THE LENS AND IMMEDIATELY REPLACED WITH A NEW LENS. THE SYMPTOMS REMAINED OU; THE PATIENT CONTINUED TO WEAR THE LENSES. ON (B)(6) 2011, THE TREATING EYE CARE PROFESSIONAL (ECP) CONFIRMED THAT THE PATIENT PRESENTED (B)(6) 2011 WITH COMPLAINT OF REDNESS AND SWELLING OU. THE PATIENT WAS DIAGNOSED WITH SPK OU AND IRITIS IN THE OS. THE +1 CELLS WERE NOTED OS. THE PATIENT WAS TREATED WITH TOBRADEX ST BID DROPS OU AND INSTRUCTED TO D/C CONTACT LENS WEAR UNTIL THE PATIENT WAS SEEN FOR F/U AND OU "HAVE RETURNED TO NORMAL." THE ECP BELIEVED THAT THE REASON FOR THE PATIENT'S DIAGNOSIS IS "DUE TO CONTACT LENS OVER WEAR." THE PATIENT CONTINUED CONTACT LENS WEAR AFTER BEING INSTRUCTED BY THE ECP TO D/C LENS WEAR. RETURN OF THE PRODUCT FOR EVALUATION WAS REQUESTED SEVERAL TIMES; THE PATIENT REFUSED TO RETURN THE PRODUCT IN QUESTION OR ANY REMAINING PRODUCT. THE PATIENT CONTINUED TO WEAR THE REMAINING LENSES OU. ON (B)(6) 2011, THE TREATING ECP REPORTED THE PATIENT NEVER RETURNED FOR F/U; NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR SOFT CONTACT LENS LPM VISTAKON NA B009K4K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SOLUTION| OPTIFREE REPLENISH MULTIPURPOSE CONTACT LENS