BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 3873155 · Received June 13, 2014

    Report

    Report Number
    2648035-2014-00293
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Removal / Correction Number
    Z-1123-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM MOLDING TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO QUANTITY DISCREPANCY WAS FOUND. NO DEVIATION OR NON-CONFORMANCE (NCR) WAS GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. THE PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR REPORT, IT WAS STATED THAT THE INTRAOCULAR LENS WAS PART OF THE Z9002 RECALL. THIS INFORMATION IS NOT ACCURATE. THE LENS IS NOT PART OF THE RECALL AS ORIGINALLY REPORTED. (B)(4). ADVERSE EVENT. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DATE OF EVENT: (B)(6) 2014. PATIENT HAD PAST LASIK SURGERY. IF EXPLANTED, GIVE DATE: (B)(6) 2014. LENS HAS BEEN DISCARDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN THE LENS HAD NOT BEEN EXPLANTED. UNEXPECTED POST OPERATIVE REFRACTION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR HAS A PATIENT WITH A Z9002 RECALLED LENS WHEREBY THE PATIENT HAS UNEXPECTED POST OPERATIVE REFRACTION. THE DATE IS UNKNOWN WHEN IT WAS DETERMINED THAT THE PATIENT WAS DIAGNOSED WITH UNEXPECTED POST OPERATIVE REFRACTION. THE PATIENT IS SCHEDULED FOR A LENS EXPLANT AND REPLACEMENT ON (B)(6) 2014. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350859 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R