BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENS

    MDR report key: 4142870 · Received September 23, 2014

    Report

    Report Number
    1033553-2014-00088
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINGLE USE OR REUSE. ANY ADDITIONAL INFO RECEIVED WITH BE REPORTED WITHIN 30 DAYS OR RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    OUR FIRM RECEIVED A PHONE CALL FROM A PATIENT'S (PT) PARENT ON (B)(6) 2014 STATING THAT THE PT EXPERIENCED REDNESS, IRRITATION, AND PAIN WITHIN FOUR DAYS OF WEAR IN OD WITH THE USE OF AN ACUVUE OASYS CONTACT LENS (CL). THE PT WORE THE LENSES ON A DAILY WEAR AND MONTHLY REPLACEMENT SCHEDULE. THE PT USED BIO TRUE LENS CARE SOLUTION. THE PARENT STATED HE/SHE TOOK THE PT TO AN URGENT CARE PHYSICIAN ABOUT 1 1/2 WEEKS AGO. THE PT'S PARENT STATED THAT THE PHYSICIAN "PUT SOME EYE DROPS AND TOLD THE PARENT THAT THE PT'S CORNEA WAS DYING". THE PARENT STATES THAT THE PHYSICIAN DID NOT PRESCRIBE EYE DROPS, BUT STATED THAT THE PT WAS GIVEN A PAIN PILL. SHE STATES THE PT WAS ALSO REMOVED FROM CL WEAR FOR 1 WEEK. THE PT'S PARENT STATED THAT THE PT ATTEMPTED TO RETURN TO CL WEAR AFTER 1 WEEK, BUT THE PT EXPERIENCED PAIN OD AGAIN. THE PT'S PARENT WAS ADVISED TO NOTIFY THE PT'S PRESCRIBING ECP OF THE SYMPTOMS AND MAKE AN APPOINTMENT FOR EVALUATION. THE PRESCRIBING ECP WAS NOTIFIED OF THE ISSUE ON (B)(6) 2014. THE PT PRESENTED TO THE PRESCRIBING ECP ON (B)(6) 2014. A CALL WAS RECEIVED ON (B)(6) 2014 FROM THE CL TECHNICIAN AT THE PT'S PRESCRIBING ECP'S OFFICE. THE FOLLOWING INFO WAS PROVIDED. THE PT PRESENTED ON (B)(6) 2014 WITH SENSITIVITY TO LIGHT, PAIN, WATERY EYE, AND LID SWELLING OD ONLY. THE PT STATED THAT HE/SHE HAD SYMPTOMS FOR ABOUT 1 WEEK. THE PT ADVISED THAT ON THE VISIT THAT HE/SHE HAD NOT WORN LENSES IN OVER A WEEK. THE CL TECH STATES, PER THE ECP'S NOTES, PT OVER-WEAR AND OVER USE OF THE LENSES. THE CL TECH STATES THAT THE PT WAS COUNSELED ON CL USE, WEAR, AND REPLACEMENT SCHEDULES AGAIN. THE PT WAS GIVEN RX FOR 1 DROP TOBRAMYCIN Q 2 HOURS FOR THE 1ST DAY, THEN QID OD. THE PT WAS SCHEDULED FOR RETURN TO THE ECP ON (B)(6) 2014. DIAGNOSIS: KERATITIS OD. ON (B)(6) 2014 THE CL TECH CALLED TO PROVIDE ADDITIONAL INFO AS FOLLOWS. THE PT RETURNED TO PRESCRIBING ECP'S OFFICE ON (B)(6) 2014 FOR FOLLOW-UP. THE CL TECH STATES THAT THE PT ENDED MEDICATION FOR OD ON (B)(6) 2014. THE CL TECH STATES THAT HE/SHE ASKED THE ECP IF THE 1 DROP Q 2 HOURS WAS HIS STANDARD OF CARE FOR THIS EVENT AND THE CL TECH STATED THAT THE ECP ADVISED THAT IT IS HIS STANDARD OF CARE . HE/ SHE STATES THE ECP ADVISED THAT IT WASN'T A SERIOUS EVENT, BUT WITHOUT TREATMENT THE EVENT COULD HAVE BEEN SERIOUS. THE PT RECEIVED AGGRESSIVE TREATMENT FOR "KERATITIS", THIS EVENT IS REPORTED AS WORST CASE. THE PT WAS REFIT IN A DAILY COMPETITOR CL ON (B)(6) 2014. THE SUSPECT CL WAS REQUESTED FROM THE PT, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE BATCH DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590938 ACUVUE OASYS BRAND CONTACT LENS SOFT CONTACT LENS LPM VISTAKON NA B00DGN8

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention BIO TRUE LENS CARE SOLUTION