BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 CLOURS BRAND CONTACT LENS

    MDR report key: 3909532 · Received June 11, 2014

    Report

    Report Number
    1033553-2014-00046
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 4, 2014
    Report Date
    June 11, 2014
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR WAS PERFORMED, (B)(4) WAS 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. THE SUSPECT PRODUCT WAS DISCARDED AND REMAINING PRODUCT FROM THE INVOLVED CARTON HAS BEEN REQUESTED IF IT IS AVAILABLE. ADDITIONAL INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MANAGEMENT REVIEW MEETINGS. DEVICE LABELING SINGE USE OR REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(4) 2014 OUR (B)(4) AFFILIATE RECEIVED A CALL FROM A PT REPORTING HAVING EXPERIENCED AN OCULAR EVENT WHILE WEARING ACUVUE 2 COLOURS CONTACT LENSES (CL). THE PT WAS WEARING THE LENSES ON A DAILY WEAR AND MONTHLY REPLACEMENT SCHEDULE. THE PT REPORTED HAVING WORN ACUVUE 2 COLOURS SINCE 2011 AND AFTER WEARING THE FIRST PAIR OF LENSES FROM THE INVOLVED CARTON FOR 12 DAYS HE/SHE EXPERIENCED DISCOMFORT OS, CLEANED THE LENS AND REINSERTED IN THE EYE BUT THE DISCOMFORT PERSISTED. THE PT'S EYE BECAME RED, IRRITATED AND ITCHY BUT THE PT FELT THE ISSUE WAS "ONLY CONJUNCTIVITIS" AND CONTINUED WEARING LENSES WITH DISCOMFORT FOUR ADDITIONAL DAYS. ON (B)(6) 2014 OUR FIRM SPOKE WITH THE TREATING DOCTOR WHO STATED ON THE PT WAS SEEN ON (B)(6) 2014 AND HAD "A CORNEAL LESION OF 1MM STAINING WITH INFILTRATES UNTIL 1/3 OF CORNEAL STROMAL TISSUE" IN THE OS. A CULTURE WAS PERFORMED WITH NEGATIVE RESULTS; THE ITEM CULTURED WAS NOT REPORTED. THE TREATMENT REGIMEN INCLUDED DOXYCYCLINE (100MG) ORALLY Q12 HRS X7 DAYS, EPITEZAN OINTMENT Q8 HRS X 5 DAYS, ZYMAR DROPS QHR X3 DAYS, THEN Q3HRS X 7DAYS AND LACRIFILM DROPS 6X QD. THE REPORTED STATED THAT THE PT'S EYE IS FINE NOW "IT'S ONLY A LITT HARD TO SEE DURING THE NIGHT". NO ADDITIONAL INFO IS EXPECTED. THIS EVENT IS REPORTED AS A WORST CASE; THE PT RECEIVED AGGRESSIVE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344563 ACUVUE 2 CLOURS BRAND CONTACT LENS SOFT CONTACT LENS LPL NA B00D0T9

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention OPTI-FREE LENS CARE SOLUTION