BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GALUCOMA SHUNT

    MDR report key: 3062812 · Received April 11, 2013

    Report

    Report Number
    3003701944-2013-00027
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO PRODUCT IDENTIFIERS WERE PROVIDED; THEREFORE, A REVIEW OF THE PRODUCT HISTORY OR PREVIOUS COMPLAINTS COULD NOT BE CONDUCTED. NOT ENOUGH INFORMATION WAS PROVIDED BY THE REPORTER TO CONDUCT A PROPER INVESTIGATION. NO ROOT CAUSE COULD BE DETERMINED. CITATION: ERICHEV, VALERY P., ASRATYAN, GAYANE K. MINI-SHUNT GLAUCOMA SURGERY. (B)(6). GLAUCOMA; UDC 617.7-007.681-089; (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REVIEW ARTICLE, THE AUTHOR PRESENTED THE MOST COMMON EVENTS OR COMPLICATIONS FOLLOWING GLAUCOMA SHUNT IMPLANTATION UNDER THE CONJUNCTIVA, AS REPORTED BY VARIOUS SURGEONS. NO PATIENTS' IDENTIFIERS WERE PROVIDED BY THE AUTHOR. WHILE SOME OF THE SURGEONS REPORTED A NUMBER OF PATIENTS, OTHERS ONLY REPORTED A PERCENTAGE OF OCCURRENCE; THEREFORE, THE EXACT NUMBER OF PATIENTS PER EVENT COULD NOT BE QUALIFIED. ONE SURGEON REPORTED THAT SHUNT IMPLANTATION HAS BEEN PERFORMED IN CONJUNCTION WITH PHACOEMULSIFICATION. THE COMPLICATIONS WERE LISTED AS FOLLOWS: SCARRING OF THE CONJUNCTIVA, ENDOPHTHALMITIS, HYPHEMA OF UP TO 2 MILLIMETERS, FIBROSIS OF THE FILTERING BLEB, SUBCONJUNCTIVAL FIBROSIS, CILIO-CHOROIDAL DETACHMENT, HYPOTONIA, DECREASE IN SHUNT FILTRATION, SHUNT OBSTRUCTION AND EROSION OF CONJUNCTIVA (ASSOCIATED WITH THIN CONJUNCTIVA). ENDOPHTHALMITIS, CONJUNCTIVAL EROSION, SUBCONJUNCTIVAL FIBROSIS AND SHUNT OBSTRUCTION WERE QUALIFIED AS THE MOST SIGNIFICANT EVENTS AND REQUIRED REMOVAL OF THE SHUNT. ONE SURGEON REPORTED NEEDLING AS AN INTERVENTION. THE REST OF THE EVENTS EITHER RESOLVED WITHOUT TREATMENT, OR WITH ADDITIONAL MEDICATION. THE AUTHOR ALSO LISTED CONTACT OF SHUNT WITH THE CORNEA OR IRIS, AND SHALLOW ANTERIOR CHAMBER AS COMPLICATIONS, BUT NO SUBSEQUENT HARM WAS REPORTED. NO CONTACT INFORMATION WAS AVAILABLE FOR THE SURGEONS; THEREFORE, FOLLOW UP COULD NOT BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156919 EX-PRESS MINI GALUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention