BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS W/HYDRACLEAR PLUS

    MDR report key: 2123090 · Received August 29, 2008

    Report

    Report Number
    1033553-2008-00104
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    May 31, 2008
    Report Date
    August 29, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT'S SPOUSE CONTACTED VISTAKON ON (B)(6) 2008 STATING THAT HER HUSBAND FELL ASLEEP WHILE WEARING ACUVUE OASYS CONTACTS LENSES (CL) AND WOKE UP COMPLAINING OF OS PAIN. THE PT'S SPOUSE STATED THAT THE PT'S PRESCRIPTION CHANGED AFTER THE PT'S OS HEALED. THE PT WAS USING SOLOCARE SOLUTION TO DISINFECT CL AND CHANGED THEM EVERY 20-30 DAYS. THE DATE THE SYMPTOMS STARTED IS UNK. ON (B)(6) 2008, THE PT WAS SEEN BY AN EYE CARE PROFESSIONAL (ECP) FOR A YEARLY EXAM. THE ECP STATED THAT THE PT HAD A SMALL ABRASION. THE PT WAS TREATED WITH VIGAMOX EYE DROPS. THE PT RETURNED TO THE CLINIC ON (B)(6) 2008 AND WAS DIAGNOSED WITH IRITIS. THE PT HAD GRADE 3 INJECTION, GRADE 2 SPK AND GRADE 3 CELLS AND FLARE. THE PT WAS TREATED WITH VIGAMOX, 1 DROP QID OS AND PRED FORTE 1 DROP EVERY 2 HRS X 2 DAYS, THEN QID X 2 DAYS. THE PT RETURNED TO THE CLINIC ON DAY (B)(6) 2008, PRED FORTE WAS SLOWLY TAPERED TO PREVENT FLARING BACK UP. THE PT HAD GRADE 2 HAZE AND GRADE 1 CELLS AND FLARE. IRITIS WAS RESOLVED ON (B)(6) 2006. VIGAMOX WAS DISCONTINUED AND STEROIDS TAPERED. ON (B)(6) 2008, THE PT WAS SEEN BY THE ECP FOR COMPLETION OF THE YEARLY FULL EYE EXAM THAT WAS INITIATED ON (B)(6) 2008. THE CORNEA WAS COMPLETELY HEALED. ON (B)(6) 2008, THE PT'S VA WITH OLD SPECTACLES WAS 20/60, 20/25 ON (B)(6) 2008 AND 20/25 ON (B)(6) 2008. DURING THE LAST EXAM, THE PT'S VA WAS 20/20 WITH SPECTACLES. THE PT HAS RETURNED TO WEARING CL. THE PT DISCARDED THE SUSPECT PRODUCT. A DEVICE HISTORY REVIEW WAS NOT DONE BECAUSE A LOT NUMBER WAS NOT AVAILABLE. NO ADD'L INFO IS EXPECTED FROM THE PT OR ECP. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS W/HYDRACLEAR PLUS SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention