BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND FOR ASTIGMATISM

    MDR report key: 3201572 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00060
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS PERFORMED; PRODUCED UNDER NORMAL MANUFACTURING CONDITIONS. THE BATCH RECORD DID NOT SHOW ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION AND STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED OUR FIRM REPORTING EYE INFECTIONS. SHE WAS WEARING ACUVUE OASYS FOR ASTIGMATISM CONTACT LENSES (CL) WHEN THE EVENT OCCURRED. THE PT WAS WEARING THE LENSES AS DAILY WEAR, REPLACING THEM EVERY 2 WEEKS AND USING CLEAR CARE LENS CARE SOLUTION. SHE REPORTED AFTER USING A BRAND NEW PAIR OF LENSES, SHE EXPERIENCED A DECREASE IN VISION OS. ON (B)(6) 2013 THE PT PRESENTED TO HER PRIMARY CARE PHYSICIAN C/O OS PAIN, SWELLING, PHOTOPHOBIA, CRUSTING, DIFFICULTY OPENING THE EYE AND THAT SHE WAS UNABLE TO SLEEP THE NIGHT PRIOR DUE TO THE SYMPTOMS. THE DOCTOR FLUSHED HER EYE WITH AN UNKNOWN SOLUTION AND PRESCRIBED CILOXAN OINTMENT AT BEDTIME. SHE WAS INSTRUCTED TO FOLLOW UP WITH HER PRIMARY EYE CARE PROFESSIONAL (ECP). ON (B)(6) 2013 THE PT CONSULTED HER ECP WHO DX HER WITH A CL RELATED INFECTION OS. A SWAB WAS DONE ON THE EYE, THE CL AND THE LENS CASE. THE TREATMENT REGIMEN INCLUDED TOBRAMYCIN 1 DROP QHR, VANCOMYCIN FORTE 1 DROP QHR AND CYCLOPENTOLATE HYDROCHLORIDE OPHTHALMIC SOLN 1-2 DROPS TID. ON (B)(6) 2013 THE ECP'S OFFICE STATED THE PT WAS SEEN ON (B)(6) 2013 AND DX A CORNEAL ULCER BUT COULD NOT PROVIDE ADDITIONAL INFORMATION AT THAT TIME. ON (B)(6) 2013 THE PT REPORTED NO IMPROVEMENT. VANCOMYCIN WAS DISCONTINUED AND VIGAMOX DROPS STARTED 6 X DAY. SHE STATED HER PAIN IS MOSTLY AT NIGHT BUT IT'S MANAGEABLE. THE PT RETURNED ON (B)(6) 2013, (B)(6)2013. ON (B)(6) 2013 THE TREATING ECP REPORTED THAT THE PT WAS DX WITH A PARACENTRAL PSEUDOMONAS INFECTION THAT HAS RESOLVED. SHE HAS A PARACENTRAL SCAR ENCROACHING THE VISUAL AXIS. BASELINE BCVA 20/25; ON (B)(6) 2013 VA COUNT FINGERS AT 5 FEET. THE PT REMAINS ON TOBRAMYCIN AND CYCLOPENTOLATE HYDROCHLORIDE OPHTHALMIC SOLN 1-2 DROPS TID, CILOXAN, PRED FORTE AND VIGAMOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295413 ACUVUE OASYS BRAND FOR ASTIGMATISM SOFT CONTACT LENS LPL VISTAKON NA B00DLMT

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| S CLEAR CARE LENS CARE SOLUTION