BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3112289 · Received May 14, 2013

    Report

    Report Number
    2648035-2013-00215
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH THE LOCATION CONTACT, SHE INDICATED THAT THE INTRAOCULAR LENS (IOL) WAS MOST LIKELY DESTROYED DURING THE EXPLANT PROCESS AND IS NOT AVAILABLE. THE PATIENT'S LEFT EYE WAS THE OPERATIVE EYE. ADDITIONALLY, IT WAS LEARNED THAT THE PATIENT DISLOCATED HIS IOL BY OVERACTIVITY FOLLOWING HIS CATARACT PROCEDURE. FOLLOWING THE EXPLANT AND IMPLANT OF A NEW IOL, HIS VISUAL ACUITY WAS 20/20. NO SURGICAL COMPLICATIONS WERE REPORTED. (B)(4). MANUFACTURING RECORDS WERE REVIEWED: ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4)- OVERACTIVITY OF PATIENT; EXPLANT OF INTRAOCULAR LENS. INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2013 AND EXPLANTED DUE TO OVERACTIVITY OF THE PATIENT ON (B)(6) 2013. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212178 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention