BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND CONTACT LENSES

    MDR report key: 2993864 · Received March 1, 2013

    Report

    Report Number
    1033553-2013-00018
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT (WHICH HAS BEEN INDICATED AS "OTHER"). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6) QUALITY AFFILIATE STATES AN EYE CARE PROFESSIONAL (ECP) REPORTED A PT EXPERIENCED A RIGHT EYE (OD) CORNEAL OPACITY AFTER 3 DAYS OF USE. THE PT IS A FIRST TIME USER OF ACUVUE OASYS CONTACT LENSES. THE PT STATED SHE DEVELOPED AN OD MINOR CORNEAL OPACITY (LEFT CORNER) ON THE THIRD DAY OF USE. THE PT ALSO REPORTED EXPERIENCING SEVERE PAIN, REDNESS, AND WATERING OD. SHE CONSULTED HER DOCTOR WHO SUGGESTED SHE STOP WEARING CONTACT LENSES FOR A MINIMUM OF TWO MONTHS AND PRESCRIBED ONIMOX GTT, EIGHT TIMES PER DAY, DOLOPAR TABLET BID, AND LVCOVAR TABLET QD. THE PT STATED THAT SHE IS FEELING BETTER NOW. THERE HAS BEEN NO CHANGE IN HER VISION AND NO SCARRING OF HER CORNEA. INFORMATION RECEIVED SUGGESTED POTENTIAL SERIOUS INJURY. DUE TO THE AGGRESSIVENESS OF THE TREATMENT, THIS EVENT IS BEING REPORTED AS WORST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89509 ACUVUE OASYS BRAND CONTACT LENSES SOFT CONTACT LENS LPM VISTAKON NA L001QKX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other