BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS CONTACT LENS

    MDR report key: 1180060 · Received June 8, 2008

    Report

    Report Number
    1033553-2008-00072
    Event Type
    Injury
    Date Received
    June 8, 2008
    Date of Event
    January 1, 2007
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR REUSE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THIS REPORT IS IN RESPONSE TO A QUESTIONNAIRE RECEIVED 6/16/08 FROM THE FDA RESULTING FROM A CONSUMER REPORTING AN ADVERSE EVENT THROUGH THE FDA'S MEDICAL DEVICE ADVERSE EVENT REPORTING PROGRAM. CONTACT DETAILS FOR THE PERSON REPORTING THE EVENT WAS NOT INCLUDED IN THE INFO SENT FROM THE FDA. LAB TESTING WAS NOT CONDUCTED, AS THE PRODUCT WAS NOT RETURNED, AS, CONTACT DETAILS FOR THE PERSON REPORTING THE EVENT WAS NOT PROVIDED. A LOT HISTORY WAS REQUESTED ON THE LOT NUMBER PROVIDED INDICATED THAT AND THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPEC. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. CONTACT INFO FOR THE PT AND TREATING EYE CARE PROFESSIONALS WAS NOT PROVIDED IN THE QUESTIONNAIRE. DIAGNOSIS CANNOT BE CONFIRMED BY THE TREATING EYE CARE PROFESSIONAL. THE PT INDICATED EXPERIENCING SWOLLEN LIDS, BLOODSHOT EYES, AND SENSITIVITY TO LIGHT, PLUS GUMMINESS AND SOME KIND OF DISCHARGE" AFTER FOUR MONTHS OF USE. THE PT'S WEAR SCHEDULE IS UNK. THE PT REPORTED BEING DIAGNOSED WITH "GPC, EKC, AND PRESCRIBED ZYLET" DROPS. NO OTHER INFO IS AVAILABLE TO INDICATE THAT THE LENS WAS A DIRECT CAUSE OF THIS INJURY NOR CAN WE RULE OUT THAT THIS INJURY WOULD NOT HAVE OCCURRED HAD THE PT NOT BEEN WEARING A CONTACT LENS. THE PRODUCT IN QUESTION WAS NOT AVAILABLE FOR RETURN FOR EVAL AND INVESTIGATION. THE LOT HISTORY REVIEW INDICATES THAT ALL RELEASE CRITERIA WERE MET. THERE ARE NO OTHER ADVERSE EVENTS DOCUMENTED IN OUR WORLDWIDE COMPLAINT HANDLING SYSTEM FOR THE LOT(S) IN QUESTION. BASED UPON AVAILABLE INFO, WE DETERMINED NO REMEDIAL ACTION IS WARRANTED. PRODUCT IN QUESTION WAS NOT AVAILABLE FOR EVAL AND/OR INVESTIGATION. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. WE WILL CONTINUE TO MONITOR, TRACK AND TREND SIMILAR EVENTS. THIS APPEARS TO BE AN UNUSUAL AND ISOLATED EVENT. ALL MDR REPORTS ARE REVIEWED AT QUARTERLY MGMT REVIEW MEETINGS. WILL REPORT ANY ADDITIONAL INFO RECEIVED WITHIN 30 DAYS SHOULD FURTHER INFO BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS CONTACT LENS SOFT CONTACT LENS LPL VISTAKON NA B005V6B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other