BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND

    MDR report key: 3732941 · Received March 25, 2014

    Report

    Report Number
    1033553-2014-00031
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    February 6, 2014
    Report Date
    March 25, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION AND LOT NUMBER WERE NOT AVAILABLE. IF ADD'L INFO IS RECEIVED, WILL REPORT WITHIN 10 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    WHILE REVIEWING A CLINIC NOTES RECEIVED ON (B)(6) 2014 FOR AN ADVERSE EVENT OS, ANOTHER ULCER WAS DISCOVERED FOR THE OTHER EYE. THE NOTES INDICATED THE FOLLOWING: (B)(6) 2014, PATIENT (PT) PRESENTED TO THE DOCTOR'S OFFICE REPORTING HAVING BEEN TOLD BY ANOTHER EYE DOCTOR THAT SHE HAD AN ULCER OS. SHE WAS TREATED WITH ZYLET AND ATROPINE AND USE THE DROPS ONCE. SHE WANTED A SECOND OPINION AND WAS SEEN BY THE REPORTING DOCTOR. THE PT REPORTED THAT SHE NORMALLY DID NOT SLEEP IN LENSES BUT SHE "DID SLEEP IN THEM 2 NIGHTS IN A ROW BECAUSE OF NO ELECTRICITY". THE PT REPORTED A HISTORY OF IRRITATION AND PAIN OU (OS>OD) THAT STARTED ON (B)(6) 2014 AND HAVING REMOVED THE LENSES EARLY IN THE EVENING BECAUSE HER EYES WERE HURTING, TEARING AND PHOTOPHOBIC. SLE REVEALED CONJUNCTIVA WHITE AND QUIET OU. CORNEAL EDEMA OU; CORNEAL ULCER OU AND CORNEAL OPACITY OU. THE PT WAS TREATED WITH ZYLET 1 DROP QHR X2 DAYS, THEN Q2HRS X3 DAYS AND INSTRUCTED TO RETURN IN ONE EVENT. VA 20/20; (B)(6) 2014, PT RETURNED "OS 1 WEEK F/U CU". SHE STATED HER OD WAS BOTHERING HER NOW AND COMPLAINED OF ITCHING OU. SLE REVEALED CONJUNCTIVA WHITE AND QUIET OU, AC DEEP AND QUIET OU; DX WITH CU OU. PT TREATED WITH VIGAMOX DROPS BID UNTIL COMPLETE THEM ZYLET DAILY UNTIL SAMPLE COMPLETE. VA 20/20. ADMINISTRATION OF ANTIBIOTIC DROPS QHR IS CONSIDERED TO BE AGGRESSIVE MEDICAL TREATMENT; THIS EVENT IS REPORTED AS WORST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174364 ACUVUE OASYS BRAND DISPOSABLE SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R