BEUDAMED
    FDA Adverse Event Summary report: N

    ACUVUE ADVANCE CONTACT LENSES

    MDR report key: 2651230 · Received August 8, 2008

    Report

    Report Number
    1033553-2008-00092
    Date Received
    August 8, 2008
    Date of Event
    November 1, 2007
    Report Date
    August 8, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED FROM (B)(4) AFFILIATE. THIS INFO INDICATES A PT WAS WEARING ACUVUE ADVANCE CONTACT LENSES (CL) AND DEVELOPED A CORNEAL ULCER OS. THE EVENT OCCURRED IN (B)(6) 2007. THE PT WAS USING COMPLETE MULTIPURPOSE SOLUTION BY AMO INC. THE DATE THE PT STARTED WEARING ACUVUE ADVANCE CL IS UNK. THE REPORT STATED THAT THE PT HAD BEEN WEARING CL 16 HOURS A DAY AND HAD "SLEPT FOR 5 HOURS WHILE WEARING ACUVUE ADVANCE CL." ON (B)(6) 2007, THE PT EXPERIENCED OS PAIN AND CORNEAL CLOUDINESS ON (B)(6) 2007. THE PT CONSULTED AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2007 AND WAS DIAGNOSED WITH A 2 MM X 2 MM CENTRAL CORNEAL ULCER. THE TREATMENT REGIMEN INCLUDED CORNEAL EPITHELIUM SCRAPING AND APPLICATION OF PIMARICIN AND LEVOFLOXACIN MEDICATION. DUE TO THE SERIOUSNESS OF THE CONDITION, THE PT WAS REFERRED TO (B)(6). THE PT WAS ADMITTED TO THAT HOSP ON (B)(6) 2008. MICROSCOPIC INSP AND CULTURE TEST WERE NEGATIVE FOR BACTERIA, FUNGI AND ACANTHAMOEBA KERATITIS. NO EVIDENCE OF RADIAL KERATONEURITIS WAS FOUND. DUE TO CENTRAL CORNEAL SCARRING OF THE OS, A CORNEAL TRANSPLANT WAS PERFORMED TO RECOVER THE PT'S VA. THE ECP FELT THE CONDITION COULD BE RELATED TO NON-COMPLIANCE TO A DAILY WEAR SCHEDULE AND ROUTINE CLEANING. THE ULCER WAS CONSIDERED TO BE INFECTIOUS BECAUSE OF THE CLINICAL FINDINGS. A LOT HISTORY REVIEW WAS NOT PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED. SUSPECT PRODUCT WAS REQUESTED, BUT NOT RECEIVED. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MGMT REVIEW MEETINGS. WILL REPORT ADD'L INFO WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE CONTACT LENSES SOFT CONTACT LENSES LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| O| S