BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE WITH HYDRACLEAR

    MDR report key: 1143666 · Received August 29, 2008

    Report

    Report Number
    1033553-2008-00103
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 29, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING FOR REUSE. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS RECEIVED FROM ANOTHER COUNTRY AFFILIATE IN 2008. ON THE SAME DAY, THE PT PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF PAIN IN THE LEFT EYE. THE PT WAS PRESCRIBED TARIVID (OFLOXANIN) OINTMENT. ON THE PREVIOUS MONTH, THE PT VISITED THE OPHTHALMOLOGY CLINIC. THE PT WAS DIAGNOSED WITH A 4MM X 4MM INFECTIOUS CENTRAL CORNEAL ULCER, AND CORNEAL EPITHELIAL EROSION AND CORNEAL OPACITY OS. THE PT'S VA WAS NOT MEASURED. THE PT WAS INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR. PAIN, CORNEAL OPACITY, EDEMA AND STAINING. ONE CORNEAL ULCER WAS LOCATED IN CENTRAL PART OF CORNEA. A CULTURE WAS NOT TAKEN. TREATMENT INCLUDED TOBRACIN (TOBRAMYCIN), BESTRON (CEFMENOXINE HYDROCHLORIDE) EYE DROPS AND CEFZON FOR ORAL ADMINISTRATION Q2H. FOLLOW UP VISIT A WEEK AFTER THE ORIGINAL DATE: THE DOCTOR NOTED SOME CORNEAL EDEMA. OPACITY STILL REMAINED. THE PT WAS INSTRUCTED TO CONTINUE TREATMENT WITH TOBRACIN (TOBRAMYCIN) AND BESTRON (CEFMENOXINE HYDROCHLORIDE) DROPS QID. FOLLOW UP VISIT THREE DAYS LATER, DOCTOR NOTED THAT CORNEAL OPACITY REMAINED THE SAME. THE PT STILL HAD REDNESS IN LEFT EYE AND THE PAIN RESOLVED. FOLLOW UP VISIT SIX DAYS LATER, DOCTOR NOTED THAT THE CORNEAL ULCER AND EROSION WERE ALMOST RECOVERED. OPACITY STILL REMAINED. TREATMENT OF "TOBRACIN (TOBRAMYCIN), BESTRON (CEFMENOXINE HYDROCHLORIDE) WAS DISCONTINUED. CONTINUE CRAVIT (LEVOFLOXACIN) QID. VA IMPROVED TO 0.4 (1.2) OS. THE PT HAS DEVELOPED ASTIGMATISM DUE TO OPACITY." FOLLOW UP THE FOLLOWING MONTH, DOCTOR INDICATED "EPITHELIAL OPACITY PARTIALLY REMAINED." FOLLOW UP VISIT THIRTEEN DAYS LATER THE DOCTOR NOTED THAT THE PT HAD "NO SUBJECTIVE SYMPTOMS. THE ASTIGMATISM WAS CONSIDERABLY BETTER. IT'S CONSIDERED THAT HER OPACITY WOULD REMAIN IN HER EYE EVEN THOUGH IT WAS ALMOST RESOLVED." THE PRODUCT IN QUESTION WAS NOT AVAILABLE FOR RETURN AND THE LOT NUMBER IS UNK. WILL REPORT ANY ADD'L INFO WITHIN 30 DAYS SHOULD AND FURTHER INFO BECOME AVAILABLE. ALL REPORTABLE ADVERSE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention