BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX FOR ASTIGMATISM

    MDR report key: 5271684 · Received December 7, 2015

    Report

    Report Number
    9681121-2015-00576
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    October 26, 2015
    Report Date
    January 7, 2016
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPL
    PMA / PMN Number
    K033919
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS KNOWN AND COMPLAINT SAMPLES FROM KNOWN LOT 31142773 WERE RETURNED FOR EVALUATION. THE COMPLAINT SAMPLES WERE EVALUATED AND WERE FOUND TO MEET MANUFACTURING SPECIFICATIONS. THERE WERE NO NON-CONFORMITIES OR DEVIATIONS NOTED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY AN EYE CARE PROFESSIONAL (ECP), A PATIENT WAS FITTED WITH TRIAL LENSES ON (B)(6) 2015 AND ADMITTED TO WEARING THE TRIAL LENSES FOR SIX (6) MONTHS WITHOUT ISSUE UNTIL THE DATE OF EVENT ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT VISITED HER ECP STATING HER CONTACTS MADE HER EYES RED AND PAINFUL. THE PATIENT PRESENTED WITH MODERATE FOREIGN BODY SENSATION, MODERATE PAIN, MODERATE REDNESS, AND WATERY DISCHARGE. PHYSICAL EXAMINATION OF THE PATIENT ON (B)(6) 2015 FOUND A MODERATELY LARGE CORNEAL ABRASION (10MMX 3MM) AND MODERATE (<50%) CORNEAL STAINING ON THE RIGHT EYE (OD) . THE EXAM ALSO FOUND THE OD RED AND PAINFUL. THERE WAS NO ANTERIOR CHAMBER REACTION, INFILTRATES OR PERMANENT SCARRING NOTED DURING THE EXAM. HOWEVER, ECP COMPLETING THE ADVERSE EVENT FORM INDICATED THAT THE PRESENCE OF AN ULCER DURING THE EXAM WAS UNKNOWN AS "THERE MIGHT HAVE BEEN A SLIGHT STROMAL INVOLVEMENT, BUT MOST LIKELY MODERATELY SEVERE CORNEAL ABRASION." THE PATIENT WAS PRESCRIBED MOXIFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION AT ONE DROP IN OD TWICE DAILY FOR 7 DAYS. A FOLLOW UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015. DURING THE FOLLOW-UP APPOINTMENT ON (B)(6) 2015, PHYSICAL EXAMINATION FOUND THAT THE CORNEAL ABRASION WAS STILL PRESENT AND IMPROVING ON OD. THE OD WAS ALSO FOUND TO BE LESS RED AND PAINFUL. THE PATIENT WAS INSTRUCTED TO CONTINUE USING THE PRESCRIBED OPHTHALMIC SOLUTION FOR AN ADDITIONAL FIVE (5) DAYS AND TO RETURN FOR FOLLOW UP EVALUATION. THE PATIENT DID NOT RETURN FOR FOLLOW UP EVALUATION UNTIL (B)(6) 2015 AT WHICH TIME THE CORNEAL ABRASION HAD COMPLETELY RESOLVED AND THE EYE WAS NO LONGER RED OR PAINFUL. THE BEST CORRECTED VISUAL ACUITY PRIOR TO AND AFTER THE EVENT WAS 20/20. THE PATIENT WAS REFIT IN A DIFFERENT BRAND OF LENSES WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802599 AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR LPL PT. CIBA VISION BATAM NA 31142773

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R