BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 1936633 · Received December 17, 2010

    Report

    Report Number
    3003701944-2010-00031
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ONE EMPTY BOX WAS RETURNED ON 12/02/2010 WITHOUT ANY PRODUCT. SINCE NO SAMPLES WERE RETURNED FOR EVAL, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE LOT NUMBER WAS IDENTIFIED AS 102822 (B)(4) AND THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO OPTONOL'S ACCEPTANCE CRITERIA. THE ROOT CAUSE IS UNK. THERE ARE NO REPORTED PROBLEMS WITH THE SHUNT. THIS REPORT IS NOT PRODUCT RELATED. ADDITIONAL INFO WAS REQUESTED VIA MAIL ON 11/29/2010; VIA FAX ON 11/29/2010; AND VIA PHONE ON 12/01/2010 AND 12/13/2010. A COMPLETED QUESTIONAIRE WAS RECEIVED FROM THE SURGEON ON 11/30/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH INITIALLY REPORTED A SURGEON DID NOT LIKE THE FIT OF THE SHUNT AND IT WAS REMOVED AND REPLACED WITH ANOTHER MODEL SHUNT. HE STATED, THERE WAS NO IMPACT OR INJURY TO THE PT. ON 11/30/2010, ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON WHO STATED THE PROXIMAL END DID NOT LAY FLUSH ON SCLERAL BED AND THE SCLERAL FLAP COULD NOT BE CLOSED TO HIS SATISFACTION. HE REPORTED THE SHUNT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 102822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention