BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 3873177 · Received June 13, 2014

    Report

    Report Number
    2648035-2014-00294
    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

    THE DATE OF EVENT IS UNKNOWN. UNEXPECTED POST OPERATIVE REFRACTION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD REVIEW FROM MOLDING TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION 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. AT THE DIOPTER INSPECTION OPERATION PROCESS THE LENSES ARE MEASURED 100% FOR DIOPTER POWER, RESOLUTION, AND ASTIGMATISM. THE INSPECTION DATA FOR THE DIOPTER POWER PROCESS AT THE MONOFOCAL BENCH WAS REVIEWED AND WAS FOUND WITHIN SPECIFICATION. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADVERSE EVENT AND PRODUCT PROBLEM. 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.

    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 IN THEIR LEFT EYE. 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
    350367 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R