BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX COLORS

    MDR report key: 9177997 · Received October 11, 2019

    Report

    Report Number
    3006186389-2019-00018
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    July 7, 2019
    Report Date
    November 7, 2019
    Manufacturer
    CIBA VISION JOHOR SDN, BHD.
    Product Code
    LPL
    PMA / PMN Number
    K133176
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D.4.: NEW INFORMATION RECEIVED. H.10.: THIS REPORT IS BEING SUBMITTED TO REPORT THE NEW INFORMATION RECEIVED REGARDING THE EVENT; THE LOT NUMBER FOR THE LEFT EYE (OS) WAS 10360128 WITH POWER +4.50 AND WAS CONFIRMED TO HAVE NOT CONTRIBUTED TO THE REPORTABLE EVENT. NO FURTHER REPORTS ARE EXPECTED FOR THE REPORTED PRODUCT.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO COMPLAINT PRODUCTS FROM THE SAME PRODUCT LINE, BUT WITH DIFFERING PARAMETERS; THIS REPORT REFERENCES THE COMPLAINT PRODUCT REPORTED WITH A REPORTED POWER OF +2.5. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO 2019-70106-01 FOR THE REPORTED UNKNOWN LOT NUMBER WITH POWER OF +4. THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. NO LOT NUMBER WAS PROVIDED AND NO SAMPLE WAS RETURNED FOR EVALUATION. DUE TO THIS, NO LOT INFORMATION COULD BE ABLE TO BE PERFORMED. THE TREND INVESTIGATION HAS BEEN COMPLETED FOR THIS COMPLAINT. NO ANY UNFAVORABLE TREND IDENTIFIED FOR THE ENTIRE EVENT RELATED TO THIS COMPLAINT FOR THE PAST MONTHS. NO ANY SIGNIFICANT OF SIGNAL OR PATTERN IDENTIFIED IN THE TREND DURING THIS REVIEW PERIOD. THE INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE TO THE COMPLAINT REPORTED BY THE CUSTOMER AS NO LOT NUMBER WAS PROVIDED AND NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE, INCONCLUSIVE-INSUFFICIENT PRODUCT OR PRODUCT DATA WAS CONCLUDED FOR THIS REPORTED COMPLAINT. INCONCLUSIVE-INSUFFICIENT PRODUCT OR PRODUCT DATA WAS CONCLUDED FOR THIS REPORTED COMPLAINT, HENCE NO CAPA WILL BE INITIATED AT THIS MOMENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON 13SEP2019 THAT A PATIENT EXPERIENCED CORNEAL ABSCESS IN THE RIGHT EYE (OD) AFTER THREE OR FOUR DAYS OF WEARING THE COMPLAINT CONTACT LENSES. THE TREATMENT MODALITY AND SYMPTOM RESOLUTION WERE STILL UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 24SEP2019 VIA A TELEPHONE CALL FROM THE OPTICIAN. IT WAS REPORTED THAT THE PATIENT TRIED TO WEAR THE COMPLAINT CONTACT LENSES IN (B)(6) 2019 AND THREE DAYS LATER, THE PATIENT REPORTED AN ABSCESS TO THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972142 AIR OPTIX COLORS LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION JOHOR SDN, BHD. NA 10360128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other