BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE WITH HYDRACLEAR

    MDR report key: 1013837 · Received March 14, 2008

    Report

    Report Number
    1033553-2008-00038
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM ANOTHER COUNTRY AFFILIATE. THIS INFORMATION INDICATES A PT WAS WEARING ACUVUE ADVANCE CONTACT LENSES (CL) AND DEVELOPED INFECTIOUS KERATITIS OU. THIS MDR IS TO REPORT EVENT IN THE OS. THE PT BEGAN WEARING ACUVUE ADVANCE CL IN 2007 AND USED SOFT ONE COOL SOLUTION. THE PT STARTED EXPERIENCING EYE REDNESS IN 2008. ON THE NEXT DAY, THE PT VISITED AN EYE CLINIC AND WAS DIAGNOSED WITH KERATITIS OU. NEW BLOOD VESSELS APPROXIMATELY 1.5MM IN LENGTH, WERE OBSERVED BETWEEN THE 12 O'CLOCK AND 2:00 O'CLOCK POSITION AT THE CORNEAL LIMBUS OF THE LEFT EYE. EYE EXAM REVEALED, "SEVERAL SMALL PUNCTUATE SPOTS", CORNEAL EDEMA AND 5-6 PERIPHERAL CORNEAL OPACITIES, EACH APPROXIMATELY 0.2MM IN SIZE. THE REPORT STATED THAT, THE ECP SUSPECTED THAT THE LESIONS OF BOTH EYES WERE INFECTIOUS. THE TREATMENT REGIMEN INCLUDED LEVOFLOXACIN DROPS 4 TIMES A DAY AND TO AVOID WEARING CL. THE PT STARTED WEARING CL AGAIN ON A WEEK LATER AT THE PT'S OWN JUDGEMENT. THE PT RETURNED TO THE CLINIC ON THE FOLLOWING DAY COMPLAINING OF EYE PAIN. ON TWO DAYS LATER, THE CORNEAL OPACITIES WERE RESOLVING AND THE PT WAS INSTRUCTED TO AVOID CL WEAR. ON FOUR DAYS LATER, CORNEAL OPACITIES AND "SLIGHT REDNESS REMAINED IN THE EYES, THE PT WAS INSTRUCTED TO CONTINUE LEVOFLOXACIN. ON A WEEK LATER, CORNEAL OPACITIES REMAINED IN THE EYES AND THE TREATMENT REGIMEN REMAINED THE SAME. A SCHIRMER TEST WAS PERFORMED WHICH REVEALED NORMAL TEAR VOLUME AT 20 MM. THE LENS (ES) IN QUESTION WAS DISCARDED BY THE PT. A LOT HISTORY REVIEW WAS PERFORMED. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. WILL REPORT ADDITIONAL INFORMATION WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA B005W30

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention