BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 1970377 · Received January 14, 2011

    Report

    Report Number
    9681121-2011-00002
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 18, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A F/U MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PT'S MOTHER THAT THE PT EXPERIENCED AN EYE INFECTION RESULTING IN SEVERAL VISITS TO THE OPHTHALMOLOGIST. ADDITIONAL INFO RECEIVED ON (B)(6) 2010, FROM THE PT STATED HE HAD PREVIOUSLY EXPERIENCED AN EYE INFECTION THAT WAS TREATED WITH TOBREX AND DISCONTINUATION OF CONTACT LENS USE. THE DATE OF THE INITIAL EYE INFECTION IS UNK. THE PT STATED THAT IN (B)(6) 2010, HE EXPERIENCED AN EYE INFECTION AND WAS TREATED BY HIS EYE CARE PROFESSIONAL ON (B)(6) 2010, WITH ERYTHROMYCIN AND ZYMAXID. F/U VISITS OCCURRED ON (B)(6) 2010, AND OTHER VISITS WERE SCHEDULED FOR (B)(6) 2010. THE PT STATED THAT HIS RIGHT EYE AND CORNEA WERE INFECTED. THE PT'S LEFT EYE WAS UNAFFECTED. THE PT IS CURRENTLY WEARING GLASSES. ADDITIONAL DOCUMENTATION RECEIVED ON (B)(6) 2010, FROM EYE CARE PROFESSIONAL STATED THAT THE PT HAD EXPERIENCED 2 PRIOR EPISODES OF BACTERIAL CONJUNCTIVITIS. THE CURRENT EVENT INVOLVED THE RIGHT EYE ONLY WITH ONE 1MM PERIPHERAL CORNEAL ULCER AND IRITIS WITH 2 INFILTRATES. THE LARGER INFILTRATE WAS 1.5MM AND LOCATIONS WERE UNSPECIFIED. THE EYE CARE PROFESSIONAL REPORTED MODERATE <50% CORNEAL STAINING AND 20/20 BEFORE CORRECTION VISUAL ACUITY PRIOR TO THE EVENT. THE PT EXPERIENCED MODERATE PAIN, SEVERE REDNESS, WATERY DISCHARGE, AND MODERATE ANTERIOR CHAMBER REACTION. THE PT WAS TREATED WITH ANTIBIOTIC DROPS EVERY 2 HOURS, STEROID DROPS 4 TIMES PER DAY, AND ANTIBIOTIC OINTMENT EVERY EVENING. F/U VISIT WAS SCHEDULED FOR (B)(6) 2011, IF EVENT HAD NOT RESOLVED. ADDITIONAL INFO RECEIVED ON (B)(6) 2011, FROM PT'S MOTHER STATED THAT THE CONTACT LENSES INVOLVED IN THIS EVENT WERE PURCHASED IN (B)(6) 2010. THE INFECTIONS HAD STARED A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX NIGHT & DAY AQUA LENS SOFT EXTENDED WEAR LPM PT CIBA VISION BATAM 9545119

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention OPTIFREE REPLENISH LENS CARE SOLUTION