BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX NIGHT & DAY AQUA

    MDR report key: 4851534 · Received June 17, 2015

    Report

    Report Number
    9681121-2015-00509
    Event Type
    Injury
    Date Received
    June 17, 2015
    Report Date
    November 13, 2015
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPL
    PMA / PMN Number
    K073459
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED TO MFR REPORT# 9681121-2015-00509 (LOT # 31122871). THE LOT NUMBER IS KNOWN AND AN UNOPENED SAMPLE FROM KNOWN LOT 31122871 WAS RETURNED FOR EVALUATION. THE COMPLAINT SAMPLE WAS FOUND TO MEET MANUFACTURING SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED TO MFR REPORT# 9681121-2015-00509 (LOT # 31122871). (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO 2015-30838-02 (31114933) FOR THE DESCRIPTION OF THE SECOND REPORT. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A TREND RELATED INVESTIGATION WAS PERFORMED; NO TREND COULD BE IDENTIFIED. THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. 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 A REPORT RECEIVED FROM A PATIENT REGARDING 'ULCERATION AND SOME SCARRING' ASSOCIATED WITH CONTACT LENS WEAR. THE PATIENT STATED SHE WAS PRESCRIBED AIR OPTIX NIGHT & DAY AQUA LENSES TO SLEEP IN, AND HAD BEEN WEARING DIFFERENT LENSES PRIOR TO (B)(6) 2014. THE PATIENT FURTHER STATED SHE WAS SEEN BY HER DOCTOR AND WAS PRESCRIBED TOBRAMYCIN 0.3% FOR BOTH EYES, ONE DROP EVERY HOUR FOR THE LEFT EYE AND ONE DROP FOUR TIMES DAILY FOR THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394749 AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR LPL PT. CIBA VISION BATAM NA 31122871

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability