BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 3060330 · Received April 11, 2013

    Report

    Report Number
    1033553-2013-00034
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. CONCLUSION: NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL MEDICAL OR PRODUCT INFO IS RECEIVED, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE FRANCHISE REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WHO STATES THAT HE/SHE IS A NURSE, CALLED TO REPORT "OASYS CONTACT LENSES ARE CAUSING ME TO HAVE CONJUNCTIVITIS TWICE." THIS REPORT IS FOR THE PT'S LEFT EYE. THE PT REPORTED VISITING THE ER 2 TIMES IN THE PAST 1.5 MONTHS. THE PT STATES FOR THE FIRST EVENT, THE DOCTOR PRESCRIBED "TOBRADEX AND THAT HAS PREDNISONE IN IT BECAUSE MY EYES WERE SO INFECTED!" THE PT IS UNABLE TO RECALL THE DATE OF THE FIRST ER VISIT OR THE FREQUENCY OF THE TREATMENT. THE PT STATES THAT "I DIDN'T WEAR THE LENSES UNTIL MY EYES WERE CLEAR AGAIN, ABOUT A WEEK LATER, THEN I STARTED WEARING THE LENSES AGAIN, ONLY TO HAVE IT HAPPEN THE SECOND TIME!" THE PT STATES THAT THE SECOND ER EVENT WAS ON (B)(6) 2013 AND THE PT WAS DIAGNOSED THE SECOND TIME WITH CONJUNCTIVITIS OU. THE PT REPORTED BEING PRESCRIBED TOBRAMYCIN DROPS, 2 GTTS Q 2H FOR THE SECOND EVENT. THE PT STATED THAT HE/SHE CONTINUED TO WEAR CONTACT LENSES AND WAS CURRENTLY WEARING THE SAME LENSES ASSOCIATED WITH THE INITIAL EVENT. WE ADVISED THE PT TO REMOVE THE CONTACT LENSES AND TO CONTACT HIS/HER EYE CARE PROVIDER FOR AN EVAL. THE PT STATED HE/SHE DID NOT SEE THE NECESSITY OF EITHER ACTION. THE PT DID NOT WANT OUR STAFF TO CONTACT THE EMERGENCY DEPARTMENT OR THE PT'S PRIMARY ECP AND REFUSED TO PROVIDE INFO ABOUT THEM. THE PT STATES HE/SHE HAS NOT RETURNED FOR FOLLOW-UP AND DOES NOT PLAN TO RETURN. ON A FOLLOW-UP CALL, (B)(4) 2013, THE PT STATED HE/SHE WILL NOT PROVIDED ANY FURTHER INFO PERTAINING TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155361 ACUVUE OASYS BRAND CONTACT LENSES SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other RENU MPS