BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 DAY TRUEYE (NARAFILICON A) CONTACT LENS

    MDR report key: 3946331 · Received July 10, 2014

    Report

    Report Number
    1033553-2014-00050
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 10, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE BATCH DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT # 4940060109 WAS PRODUCED UNDER NORMAL MANUFACTURING CONDITIONS. TWENTY-TWO SEALED BLISTERS FROM LOT # 4940060109 WERE RECEIVED FOR EVALUATION. TEN OF THOSE LENSES WERE EVALUATED FROM THE SAME LOT AND THE LENSES MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS TESTED AND THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CALL WAS RECEIVED FROM A CL (CONTACT LENS) TECHNICIAN AT AN ECP'S (EYE CARE PROFESSIONAL) OFFICE TO REPORT THAT A PT (PATIENT) HAD BEEN DIAGNOSED WITH IRITIS OD. IT IS REPORTED THAT THE PT OPENED 1-30 PACK OF THE ACUVUE 1 DAY TRUEYE LENSES OD RX AND HAD ONLY 3 LENSES FROM THE PACKAGE. THE CL TECHNICIAN ADVISED THAT ALL 3 LENSES FELT UNCOMFORTABLE DURING WEAR OD. IT WAS ADVISED THAT THE PT WOKE UP ON THE MORNING OF (B)(6) 2014 WITH PAIN, REDNESS, BURNING, AND LIGHT SENSITIVITY OD, AND CALLED ECP FOR EVALUATION. SHE STATES THAT THE PT WAS DIAGNOSED WITH IRITIS OD WITH INFILTRATES. SHE ALSO ADVISED THAT THE PT WAS GIVEN RX DROPS OF PREDFORTE OD. THE MEDICAL RECORDS WERE RECEIVED FROM THE ECP ON (B)(6) 2014: DATE OF VISIT (B)(6) 2014. CHIEF COMPLAINT: OD BURNS, WATERY, LIGHT SENSITIVE; NOT WEARING CL'S. JUST STARTED TODAY. PT AWOKE AT 9:00 AND OD STARTED BURNING AND GOT WORSE. OD - 20/20 - A DRAWING DEPICTS RIGHT EYE WITH 2 STERILE INFILTRATES @ 10:00 AND 12:00. SLIT LAMP EXAM: LID OD: VERY SLIGHT HYPEREMIA; CONJ: GRADE 3 INJECTION 360 OD; CORNEA: 2 STERILE INFILTRATES 12:00 AND 10:00 O'CLOCK ABOVE THE PUPIL OD, SURFACE LIGHTLY STAINS OVER INFILTRATES, NO THINNING OR EXCAVATION; ANTERIOR CHAMBER: DEEP OD, NO NOTICEABLE CELLS OR FLARE OD; DIAGNOSIS: IRITIS FROM CORNEAL INFILTRATES OD DUE TO DEFECTIVE CONTACT MOST LIKELY; TREAT: PRED FORTE 1% HOURLY TODAY OD, EVERY 2 HOURS OD TOMORROW, THEN QID X 7 DAYS OD; RECHECK - 3 DAYS. DATE OF VISIT: (B)(6) 2014; F/U FROM (B)(6) 2014 OD IRITIS - RX PRED FORTE - STILL USING DROPS; GLASSES: DEPICTS: SLIGHT SURFACE STAIN, NO OTHER SURFACE STAIN ON OTHER TWO RESOLVING INFILTRATES; LID - NO EDEMA, NO HYPEREMIA; CONJ - NO EDEMA, NO HYPEREMIA; CORNEA - 3 RESOLVING INFILTRATES, ONLY ONE SHOWS SLIGHT SURFACE STAIN W/PL; ANTERIOR CHAMBER - DEEP W/O CELLS OR FLARE; DIAGNOSIS - "RESOLVING CORNEAL INFILTRATES FROM DEFECTIVE SILICONE HYDROGEL 1 DAY TRUEYE;" TREAT - CONTINUE PRE FORTE 1% QID ANOTHER 7 DAYS; RECALL - 1 WEEK. DATE OF VISIT: (B)(6) 2014: F/U - HAS NOT HAD CL'S ON YET; GLASSES: OD: 20/20 SLOW; OD EYE WHITE AND QUIET; PT REPORTS EYE FEELS NORMAL NOW; SLIT LAMP: EYE AND ADNEXA NORMAL OD: CORNEA - 2 RESOLVING INFILTRATE - NO EPITHELIAL STAIN OVER INFILTRATES; DIAGNOSIS - RESOLVING INFILTRATES; TREAT - STOP PREDNISONE; ORDER TRIAL LENSES. CALL RECEIVED FROM THE ECP'S OFFICE ON (B)(6) 2014 ADVISED THAT THE PT TRIED 1 TRIAL LENS OD OF THE 1 DAY TRUEYE LENSES AND STATES THAT THE CL FELT WEIRD, SO THE PT REMOVED THE OD CL IMMEDIATELY. SHE STATES THAT THE PT ADVISED THAT SHE NO LONGER WANTED TO BE PLACED IN THE ACUVUE 1 DAY TRUEYE LENSES AND ADVISES THAT THE PT WILL NOW BE PLACED IN A COMPETITOR CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404576 1 DAY TRUEYE (NARAFILICON A) CONTACT LENS SOFT CONTACT LENS LPL VISTAKON NA 4940060109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention