BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 2003943 · Received February 24, 2011

    Report

    Report Number
    9681121-2011-00008
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 28, 2011
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. THE UNOPENED COMPLAINT PRODUCT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS ON THE SAME PT INVOLVING TWO PRODUCT LOT NUMBERS. REFER TO MEDWATCH 9681121-2011-00001 FOR A DESCRIPTION OF THE FIRST REPORT. IT WAS REPORTED BY THE EYECARE PROFESSIONAL THAT A PT PRESENTED AT THE OFFICE AND WAS DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE. THE PT WAS TREATED WITH CYCLOPLEGIC AND ZYMAXID. THE PT WAS SCHEDULED FOR A F/U EXAM VISIT ON (B)(6) 2010. ADDITIONAL INFORMATION REC'D ON (B)(6) 2010 FROM THE EYECARE PROFESSIONAL INDICATED, THAT THE ULCER WAS LOCATED IN THE UPPER TOP OF THE CORNEA. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE EYECARE PROFESSIONAL INDICATED, THAT THE EVENT CAUSED SEVERE PAIN, REDNESS, AND CORNEAL STAINING. A 5.0 MM INFILTRATE AND 5.0 MM ULCER WAS LOCATED IN THE SUPERIOR REGION OF THE CORNEA. F/U APPOINTMENTS WERE SCHEDULED ON (B)(6) 2010, AND (B)(6) 2011. PERMANENT SCARRING ON THE CORNEA WAS NOTED. THE VISUAL ACUITY READING PRIOR TO THE EVENT WAS 20/25. THE VISUAL ACUITY READING AFTER THE EVENT WAS 20/30. THE EVENT HAS RESOLVED AND CONTACT LENS WEAR HAS RESUMED. A SECOND LOT NUMBER WAS ALSO REPORTED AND DOCUMENTED IN THIS REPORT.

    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 0576048

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention