BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES TORIC VISITINT (AQUA RELEASE)

    MDR report key: 2831640 · Received November 9, 2012

    Report

    Report Number
    9610813-2012-00014
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K050065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. RETAINED PRODUCT FROM THE SAME LOT WAS EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. 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

    IT WAS REPORTED BY A PT THAT UPON OPENING THE NEW CONTACT LENS AND PLACING IT ON THE EYE THEY NOTICED THAT SOMETHING WAS WRONG ALONG. THE PT EXPERIENCED BLURRED VISION AND A STINGING SENSATION. THE PT ATTEMPTED TO REMOVE THE CONTACT LENS, BUT WAS UNSUCCESSFUL AND THE EYE BECAME "MORE AND MORE IRRITATED AND DID NOT IMPROVE DESPITE RINSING WITH SALINE SOLUTION." THE PT WENT TO AN EYE CARE PROVIDER TO HAVE THE LENS REMOVED. AN EMPLOYEE NOTICED THAT THE LENS HAD "ALMOST CRACKED IN THE EYE" WHEN HE WAS ABLE TO REMOVE THE LENS. THE PT REPORTS "INDESCRIBABLE PAIN" AND STATED THAT THERE WAS A FOREIGN BODY IN THE EYE. THE PT PROCEEDED TO THE ACCIDENT AND EMERGENCY DEPARTMENT. THE PT'S EYE WAS ANAESTHETIZED, CONTRAST LIQUID WAS INJECTED, AND THE DOCTOR REMOVED A "RUBBER/PLASTIC-LIKE SUBSTANCE" WHICH THEY PRESUME COULD BE GLUE OR SOMETHING FORM THE PACKAGING. IT IS INDICATED THAT THERE WAS "A KIND OF THIN FILM" ON THE CORNEA AND THE DOCTOR TRIED TO CLEAN THE EYE BUT WAS UNSUCCESSFUL. ANOTHER DOCTOR WAS CALLED AND HE WAS CONCERNED ABOUT A SERIOUS INJURY TO THE CORNEA AND WAS TAKEN TO AN OUTPATIENT EYE CLINIC. AT THIS CLINIC, TWO EYE SPECIALISTS LOOKED AT THE EYE AND FOUND THE "UPPER LAYER OF A LARGE PART OF THE CORNEA HAD BEEN DAMAGED," CORRESPONDING TO A SERIOUS ABRASION. THEY WERE TREATED WITH CHLORAMPHENICOL AND A PATCH ON THE EYE. ON A FOLLOW-UP VISIT THE NEXT DAY. IT WAS INDICATED BY THE DOCTOR THAT THE CORNEA WAS INJURED TO A DEPTH OF APPROXIMATELY 5MM. THE PT WAS SENT HOME WITH A CONTINUED TREATMENT OF CHLORAMPHENICOL FOR A REGIMEN OF THREE TIMES A DAY, WITH REST, AND IBUPROFEN AND PARACETAMOL FOR THE PAIN. THREE DAYS LATER, THE PT WAS SEEN FOR A FOLLOW-UP APPOINTMENT AND THE INJURY DID NOT GET 'WORSE/INFECTED" OVER THE WEEKEND. THE PT WAS SEEN ON MONDAY AND WAS TOLD THE HEALING WAS NOT YET COMPLETE, THAT THE CORNEA WAS STILL "UNSTABLE" AND UNEVEN, AND THAT THE VISION WAS REPORTED AS STILL BLURRED. IT WAS RECOMMENDED THAT THE PT CONTINUE CHLORAMPHENICOL THREE TIMES A DAY FOR ONE WEEK, EYE REST, WITH NO TELEVISION OR COMPUTER USE. THE PT WEARS SUNGLASSES TO PROTECT AGAINST THE LIGHT. ANOTHER FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES TORIC VISITINT (AQUA RELEASE) LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N0518664

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other