BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT QUICK

    MDR report key: 6065607 · Received October 29, 2016

    Report

    Report Number
    3004178847-2016-00035
    Event Type
    Injury
    Date Received
    October 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZP
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR REPORT, THE UDI NUMBER WAS LISTED AS N/A (NOT APPLICABLE). THIS REPORT REFLECTS THE CORRECTION AS FOLLOWS. UDI #: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - CONSEPT QUICK NEUTRALIZING SOLUTION LOT PT0497. (B)(4). DEVICE EVALUATION: THE SOLUTION WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. CHEMISTRY TESTING WAS PERFORMED. PRODUCT MET SPECIFICATION. RETAINED SAMPLE: CHEMISTRY TESTING WAS PERFORMED ON THE RETAIN SAMPLE AND RESULTS SHOW PRODUCT MET SPECIFICATION. MANUFACTURING RECORD REVIEW: A REVIEW OF THE RECORDS WAS PERFORMED. THE RECORDS FOR PRODUCTION PROCESS WERE FOUND TO BE ACCEPTABLE, ALL TESTING ITEMS WERE COMPLETED AND MET SPECIFICATIONS, INCLUDING INCOMING CHEMICAL MATERIALS TESTING, PRIMARY AND SECONDARY PACKAGING MATERIALS INSPECTION, PRODUCT PHYSICAL APPEARANCE INSPECTION, BULK AND FINISHED PRODUCT CHEMICAL TESTING AND MICROBIAL TESTING, STERILIZATION RECORDS, ENVIRONMENT MONITORING AND WATER SYSTEM MONITORING. THERE WAS NO SAME OR SIMILAR NON-CONFORMING MATERIAL RECORD, OR RELATED PROCESS/MATERIAL CHANGE. THERE WAS NO NON-CONFORMANCES RELATED TO THIS COMPLAINT. IN CONCLUSION, REPORTED LOT WAS DEEMED ACCEPTABLE FOR RELEASE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE RESULTS OF THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. REPORTED ISSUE WAS PROBABLY CAUSED BY USE ERROR. PRODUCT DIRECTIONS FOR USE INDICATE THAT CONSEPT QUICK SHOULD NOT BE USED WITH COLORED SOFT CONTACT LENSES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FEMALE PATIENT'S MOTHER THAT THE PATIENT EXPERIENCED RED EYES AND REPORTEDLY HER EYES FELT ITCHY WITH USE OF CONSEPT QUICK. SHE HAD SYMPTOMS FROM (B)(6) 2016, WHEN WEARING LENS. PATIENT WENT TO SEE AN OPHTHALMOLOGIST TWICE AND RECEIVED 2 EYE DROPS. SHE USED CONSEPT QUICK BEFORE, BUT DID NOT HAVE SUCH SYMPTOMS. IT WAS REPORTED THAT THE PATIENT CARED FOR HER COLOR CONTACT LENS WITH CONSEPT QUICK. IT WAS EXPLAINED THAT THE PRODUCT IS NOT FOR THE CARE OF COLOR CONTACT LENSES. IN FOLLOW UP, THE SYMPTOMS OF RED EYES AND ITCHINESS WERE RELIEVED. PATIENT USED UP EYE DROPS; THE NAME OF THE DROPS WAS UNKNOWN. THE DOCTOR DID NOT TELL THE PATIENT THAT USING CONSEPT QUICK WAS THE CAUSE OF SYMPTOMS. DOCTOR TOLD PATIENT TO REST FROM USING CONSEPT QUICK BECAUSE PATIENT HAD SUCH SYMPTOMS ONLY WHILE SHE USED THE PRODUCT. NEUTRALIZING SOLUTION WAS USED WITH THE PRODUCT AND A SEPARATE MDR WILL BE FILED FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716711 CONSEPT QUICK SOLUTIONS LZP ABBOTT MEDICAL OPTICS 07167X ZA05439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention