BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3183240 · Received June 21, 2013

    Report

    Report Number
    2648035-2013-00260
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED WITH ALL PROCESS OPERATIONS IN COMPLIANCE. NO DEVIATIONS OR NON-CONFORMANCES (NCR) RELATED TO THE CUSTOMER'S REPORT WERE GENERATED. THE MANUFACTURING RECORDS AND RELATED DOCUMENTS SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CYSTOID MACULAR EDEMA REFERS TO RETINAL SWELLING WITH CYST FORMATION IN MACULA. THIS CONDITION IS ON THE LIST OF KNOWN CLINICAL HAZARDS AND MAY APPEAR FOR A FEW DAYS OR WEEKS AFTER CATARACT SURGERY. ALSO, THE CONDITION CAN HAPPEN EVEN IF THE SURGERY WAS PERFORMED PERFECTLY. OTHER CAUSES OF CYSTOID MACULAR EDEMA INCLUDE DIABETES AFFECTING THE RETINA, OR A VARIETY OF CONDITIONS CAUSING CHRONIC INFLAMMATION INSIDE THE EYE. BASED ON THE MANUFACTURING RECORD REVIEW, NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED FOR THE REPORTED EVENT. DATE OF THIS REPORT: (B)(6) 2013. DATE RECEIVED BY MANUFACTURER: 05/23/2013. EXPIRATION DATE: 09/05/2015. DEVICE MANUFACTURE DATE: 09/05/2012. TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CYSTOID MACULAR EDEMA (CME) AFTER IMPLANTATION OF AN INTRAOCULAR LENS IN THE RIGHT EYE. THE FINDING WAS NOTED ON (B)(6) 2013, ALMOST ONE MONTH AFTER THE 3-MONTH STUDY VISIT. THE PATIENT WAS TREATED WITH DUREZOL AND BROMDAY. THE PATIENT RETURNED FOR ANOTHER VISIT ON (B)(6) 2013 AND THE CME WAS STILL PRESENT. THE PATIENT CONTINUED TREATMENT AND THE CONDITION HAD RESOLVED BY (B)(6) 2013 WITH GOOD VISUAL OUTCOME. THE PHYSICIAN BELIEVES THIS EVENT TO BE CAUSED BY OCULAR SURGERY AND IS A KNOWN RISK OF CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283737 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention