BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 2041167 · Received March 30, 2011

    Report

    Report Number
    9681121-2011-00013
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    July 2, 2010
    Report Date
    March 8, 2011
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PRODUCT INVESTIGATION, 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 ON (B)(6) 2011 BY THE PT, THAT SHE EXPERIENCED BURNING AND SCRATCHING AS A RESULT OF WEARING CONTACT LENSES FOR THE PAST 18 MONTHS. THESE SYMPTOMS SOMETIMES OCCUR WITHIN A WEEK OF WEARING A NEW PAIR OF CONTACT LENSES. THE CONSUMER REPORTED TO HAVE ALLERGIES AND LAST YEAR SHE WAS TREATED FOR A SCRATCH IN THE LEFT EYE AFTER TRYING TO INSERT ONE OF HER LENSES. THE PT STATES SHE WAS PRESCRIBED TOBRAMYCIN 1 DROP EVERY 2 HOURS FOR THE FIRST TWO DAYS AND 4 TIMES A DAY FOR 5 DAYS. THE CONSUMER REPORTS THE EVENT HAS RESOLVED. ADDITIONALLY, THE CONSUMER REPORTED A LATEX ALLERGY AND THE PT WAS INFORMED THE CONTACT LENSES DO NOT CONTAIN LATEX. THE PT STATED THE DOCTOR BELIEVES HER SYMPTOMS ARE ALLERGY RELATED AND ADVISED SHE USE PATANOL DROPS. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE EYE CARE PROFESSIONAL (ECP), INDICATED THE PT PRESENTED ON (B)(6) 2010 COMPLAINING OF MODERATE PAIN, ITCHING, BURNING, REDNESS, AND EYE IRRITATION. THE ECP STATED THE PT OVER WEARS HER LENSES AND WAS DIAGNOSED WITH A CENTRAL CORNEAL ABRASION ON THE LEFT EYE AND WAS TREATED WITH A GENTAMICIN PATCH. THE PT DID NOT RETURN FOR F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT CIBA VISION BATAM 9631090

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other