BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVUE OASYS

    MDR report key: 1076515 · Received April 16, 2008

    Report

    Report Number
    1033553-2008-00052
    Event Type
    Other
    Date Received
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO CONCLUSION CAN BE DRAWN. LAB TESTING WAS NOT CONDUCTED, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE REPORTING OPTOMETRIST. FAILURE ANALYSIS WAS NOT CONDUCTED FOR THIS EVENT AS THE CRITERIA FOR A FAILURE INVESTIGATION WAS NOT MET PER OUR PROCEDURE. 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 AND LOT NUMBER WERE NOT AVAILABLE FOR EVAL AND INVESTIGATION. BASED UPON AVAILABLE INFO, WE DETERMINED NO REMEDIAL ACTION IS WARRANTED. PRODUCT 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. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. NO CONCLUSION CAN BE DRAWN. THE PT WAS DIAGNOSED WITH SPK (SUPERFICIAL PUNCTATE KERATITIS) AND DRY EYES. SPK DOES NOT LEAD TO DISABILITY OR PERMANENT IMPAIRMENT, THEREFORE SPK IS NOT INCLUDED IN ADVERSE EVENT TREND ANALYSIS.

    Description of Event or Problem · 1

    RECEIVED INFO FROM ATTORNEY ALLEGING "SIGNIFICANT INJURY" WHILE WEARING ACUVUE OASYS BRAND LENSES. MEDICAL RECORDS RECEIVED INDICATE SUPERFICIAL PUNCTATE KERATITIS (SPK) OU WITH SUBEPITHELIAL INFILTRATES (SEI) AND DRY EYES. THE PT PRESENTED TO THE OPHTHALMOLOGIST'S OFFICE FIRST IN 2007. NOTE STATES "NO SIGN OF INFECTION." STATES NO EXTENDED WEAR AND 2 WEEK REPLACEMENT. PT WAS TREATED WITH PRED FORTE TID AND REFRESH DROPS. COLLAGEN PUNCTAL PLUGS WERE INSERTED FOR DRY EYES. SEQUENCE OF EVENTS IS UNCERTAIN AS DATES HAVE BEEN REDACTED OR TRUNCATED FROM EXAM RECORDS. RECORD DATED 2008, INDICATE VA'S OF 20/20-1 AND 20/20 PT WAS REFIT IN A CIBA DAILIES LENS. THE PT ALSO SUBMITTED A VOLUNTARY MEDWATCH REPORT AND A QUESTIONNAIRE WAS RECEIVED FROM THE AGENCY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other