BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERT

    MDR report key: 2942040 · Received February 4, 2013

    Report

    Report Number
    2648035-2013-00072
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K961242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFUNCTION. PRIOR TO RELEASE TO MARKET THE CARTRIDGE MET ALL MANUFACTURING SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME IS GOOD.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD WAS REVIEWED AND ALL RESULTS WERE WITHIN SPECIFICATION. NO NON-CONFORMANCES WERE GENERATED DURING THE MANUFACTURING PROCESS OF THIS LOT. ALL MANUFACTURING OPERATIONS WERE IN COMPLIANCE. NO DEVIATIONS WERE FOUND IN THE STERILIZATION PROCESS. THE DOCUMENTATION SHOWED THAT ALL MODEL PSCST30 CARTRIDGES WERE RELEASED WITHIN SPECIFICATION WHEN THIS LOT WAS COMPLETED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN ABBOTT MEDICAL OPTICS INTRAOCULAR LENS (IOL) WHICH NEEDED TO BE EXPLANTED IN THE SAME PROCEDURE. IT WAS STATED THAT THE CARTRIDGE "SPLIT" OPEN AND THE LENS WAS WEDGED IN THE PATIENT'S EYE. IN ADDITION, IT WAS STATED THAT THERE WAS AN INCISION ENLARGEMENT WHILE REMOVING THE LENS. THE DATE OF EVENT, AND THE CARTRIDGE AND IOL BRAND AND MODEL WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. A SEPARATE MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED FOR THE IOL AND CARTRIDGE. THIS MDR IS BEING SUBMITTED FOR THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45933 SILVERT SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS PSCST30 CK01602

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ABBOTT MEDICAL OPTICS IOL (BRAND UNKNOWN)