BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND

    MDR report key: 3697691 · Received February 28, 2014

    Report

    Report Number
    1033553-2014-00021
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 28, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A PT (PT) CONTACTED OUR FIRM REPORTING HAVING EXPERIENCED A CORNEAL ULCER (CU) WHILE WEARING ACUVUE OASYS CONTACT LENSES (CL) AND WAS TOLD SHE MAY HAVE A SCAR ON HER CORNEA AFTER THE ULCER HEALS. THE PT WAS SEEKING MEDICAL REIMBURSEMENT AND PAIN AND SUFFERING. THE PT SAID THE LENSES WORN WHEN THE INJURY OCCURRED WERE GIVEN TO HER BY THE ACCT, THEY WOULD NOT ALLOW HER TO ORDER CL, THE REASON WAS NOT PROVIDED. THE PT WAS ON A TWO WEEK REPLACEMENT SCHEDULE AND WEARING THE LENSES AS EXTENDED WEAR; THE LENS CARE SOLUTION IS UNK. ON (B)(6) 2013, THE PT AWAKENED WITH OS REDNESS, PAIN, BLURRY VISION, FBS OS WAS SEEN BY AN OPTOMETRIST THAT AFTERNOON. THE PT WAS DX WITH A CU AND TREATED WITH ATROPINE AND ZYLET DROPS. THE PT WANTED A SECOND OPINION AND SAW AN OPHTHALMOLOGIST THE SAME DAY. THE PT WAS GIVEN A RX FOR VIGAMOX DROPS QHR X2 DAYS, THEN Q2 HRS WHILE AWAKE UNTIL (B)(6). ON (B)(6) 2014, THE DOCTOR'S OFFICE PROVIDED A LIMITED AMOUNT OF INFO STATING THE PT WAS SEEN ON (B)(6) 2014, RETURNED, AND SHE HAD AN EYE OPACITY. WE HAVE MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO COLLECT ADDITIONAL MEDICAL INFO ADMINISTRATION OF ANTIBIOTIC DROPS QHR IS CONSIDERED TO BE AGGRESSIVE MEDICAL TREATMENT; THIS EVENT IS REPORTED AS WORST CASE. THE PRODUCT IN QUESTION AND LOT NUMBER WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125250 ACUVUE OASYS BRAND DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R