BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES AQUA RELEASE

    MDR report key: 4212978 · Received October 24, 2014

    Report

    Report Number
    1065835-2014-00019
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 25, 2014
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    MVN
    PMA / PMN Number
    K050065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. RETAINED PRODUCT FROM THE SAME LOT WAS EVALUATED AND ALL TESTING WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MFG 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 ON (B)(6) 2014 BY THE PT THAT SHE WORE 6 DAYS' WORTH OF CONTACTS FOR EACH EYE AND ON THE 6TH DAY, SHE NOTICED MAJOR IRRITATION IN THE LEFT EYE. THE PT VISITED THE DOCTOR WHO INDICATED THAT THE PT HAD A "CATARACT ULCER" CAUSED BY THE CONTACT LENSES AND SHE WAS PRESCRIBED ANTIBIOTICS AND STEROID DROPS. ADDITIONAL INFO RECEIVED FROM THE PT ON (B)(6) 2014 STATING THAT SHE WAS SEEN BY THE EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2014 AND WAS DIAGNOSED WITH AN ULCER. THE PT WAS PRESCRIBED "OFLOXACINTO" 1 DROP EVERY THREE HOURS. SHE HAS A FOLLOW UP APPOINTMENT ON(B)(6) 2014. ADDITIONAL INFO WAS RECEIVED FROM THE TREATING ECP ON (B)(6) 2014 WHO STATED THAT THE PT WAS SEEN IN THERE OFFICE ON (B)(6) 2014 AND WAS DIAGNOSED WITH A BACTERIAL CORNEAL ULCER AND THE PT HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2014. THE LOCATION OF THE ULCER WAS NOT ABLE TO BE CONFIRMED AT THAT TIME, HOWEVER IT WAS NOTED THAT SUPERFICIAL ULCERATIONS WERE PRESENT. THE PT HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2014. ADDITIONAL INFO RECEIVED ON (B)(6) 2014 FROM THE ECP VIA AN ADVERSE EVENT FORM WHICH STATED THAT THE EVENT HAPPENED ON (B)(6) 2014 IN THE LEFT EYE. THE PT EXPERIENCED A FOREIGN BODY SENSATION, MILD REDNESS, NO DISCHARGE OR ANTERIOR CHAMBER REACTION. THE ULCER WAS LOCATED IN THE MID-PERIPHERAL AND LESS THEN 1 MM IN SIZE. THERE WAS ONE INFILTRATE PRESENT BENEATH THE ULCER, WHICH WAS LOCATED MID-PERIPHERAL AND LESS THEN 1MM IN SIZE. THERE WAS TRACE CORNEAL STAINING THAT COVERED LESS THAN 50% OF THE CORNEAL SURFACE. IT WAS UNK IF THERE WAS ANY CORNEAL SCARRING. THE CLINICAL DIAGNOSIS WAS BACTERIAL CORNEAL ULCER AND THE PT WAS PRESCRIBED OCULOX 0.3% IGT IN THE LEFT EYE EVERY 3 HOURS (QID. THE PT WAS SCHEDULED FOR A FOLLOW UP APPOINTMENT ON 09/26/2014 AND AT THAT TIME THE PT HAD NOT RESUMED LENS WEAR BECAUSE THEY WERE STILL HEALING. ADDITIONAL INFO RECEIVED ON (B)(6) 2014 FROM THE ECP VIA THE PT'S MEDICAL RECORDS FROM THE APPOINTMENT ON (B)(6) 2014 WHICH STATED THAT THE PT'S SYMPTOMS WERE SLIGHTLY BETTER BUT STILL BOTHERING HER AND SHE HAD AN ITCHY RIGHT EYE AND IT FELT LIKE SOMETHING WAS IN HER EYE ALL THE TIME. THE PT EXPERIENCED THESE SAME SYMPTOMS FOUR YEARS AGO AT HER LAST EYE EXAM AND SHE WAS TOLD THAT THERE WAS A "COLD IN HER EYE". THE PT DOES NOT SLEEP IN THE LENSES. THE CORNEA REVEALED ULCERATION IN THE LEFT EYE THAT WAS HEALED WITH NO STAIN PICKUP BUT SLIGHT HAZE PERSISTED. IMPRESSIONS WERE A BACTERIAL CORNEAL ULCER THAT WAS IMPROVING IN THE LEFT EYE. THE TREATMENT GIVEN WAS OCUFLOX QID AND TO ADD PRED QID IN THE LEFT EYE. THE PT DID NOT RESUME CONTACT LENS WEAR AT THAT TIME. ADDITIONAL INFO RECEIVED FROM THE ECP VIA MEDICAL RECORDS ON (B)(6) 2014 FOR THE PT'S FOLLOW UP VISIT ON (B)(6) 2014 WHICH STATED THAT THE PT'S CHIEF COMPLAINT WAS THAT SHE WAS STILL FEELING A LITTLE ITCHY AND STILL WAS IRRITATED TOWARDS END OF DAY. SHE WAS USING BOTH OCUFLOX AND PRED. HER EYE WAS NOT AS WATERY, STILL HAD A BIT OF FOREIGN BODY SENSATION. HER VISUAL ACUITY SEEMED TO BE THE SAME AND UNAFFECTED AND THE PT HAD NOT WORN GLASSES OR CONTACT LENSES DURING HER VISIT. THE PT'S CORNEA SHOWED THE LEFT EYE RESOLVING K INFILTRATES, 0.1MM EPI DEFECT WITH UNDERLYING STROMAL HAZE/INFILTRATE VS. STROMAL SCAR (2MM IN SIZE). LOCATION WAS SUPERIORLY AT 11 AND 1 O'CLOCK AND 3RD AT 3 O'CLOCK. CONJUNCTIVA WAS CLEAR IN BOTH EYES. SCLERA AND ANTERIOR CHAMBER IN BOTH EYE SHOWED RESOLVING ULCERS X3, V SMALL EPI DEFECT ABOVE INFILTRATE. THE DIAGNOSIS WAS MARGINAL CORNEAL ULCER. THE TREATMENT PLAN FOR THE CORNEA WAS TO DECREASE PRED TO BID OS, OCUFLOX TID, ARTIFICIAL TEARS Q 1 HR. RCT 1 WEEK FOR MED CHECK. UNAIDED VISUAL ACUITIES WERE AS FOLLOWS: OD: DVA 20/50++, NVA 20/20; OS: DVA 20/50, NVA 20/20; OU: DVA 20/40+, NVA 20/20. ADDITIONAL INFO RECEIVED ON (B)(6) 2014 FROM THE ECP WHICH STATED THAT THE PT RETURNED FOR HER LAST FOLLOW UP APPOINTMENT ON (B)(6) 2014 (MEDICAL RECORDS WERE NOT RECEIVED AT THAT TIME) AND THE PT DID NOT REQUIRE ANY ADDITIONAL FOLLOW UP. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678579 FOCUS DAILIES AQUA RELEASE LENS, CONTACT (DISPOSABLE) MVN CIBA VISION CORPORATION A0392312

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other