BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE IRIS RETRACTOR

    MDR report key: 14797164 · Received June 24, 2022

    Report

    Report Number
    3003398873-2022-00040
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 1, 2022
    Report Date
    September 27, 2022
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HOC
    UDI-DI
    07612717012233
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN SECTIONS H.6 AND H.10. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. LOT NUMBER OF DEVICES IS UNKNOWN THIS IS A CLINICAL LITERATURE RESEARCH; NO FURTHER INFORMATION CAN BE OBTAINED FOR THE CASES MENTIONED IN THE STUDY. THE STUDYS PURPOSE WAS TO COMPARE THE INCIDENCE OF COMPLICATIONS BETWEEN FLEXIBLE IRIS RETRACTOR (FIR) AND A SIMILAR OPERATION TECHNIQUE. THE STUDY DESCRIBES THAT THE RATE FOR COMPLICATIONS IS HIGHER WITH THE ALTERNATIVE TECHNIQUE, THAN USING THE FIR. SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE IS NO NEW RISK DISCOVERED FOR THE USE OF FLEXIBLE IRIS RETRACTORS. NO FURTHER ACTIONS REQUIRED. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE ARTICLE STATED THAT WHILE USING THE IRIS HOOK THEY NOTED POSTERIOR CAPSULE RUPTURE OR ZONULAR FIBER RUPTURE WITH OR WITHOUT VITREOUS LOSS AND POST OPERATIVELY INTRAOCULAR PRESSURE WAS HIGH IN PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328820 FLEXIBLE IRIS RETRACTOR CLIP, IRIS RETRACTOR HOC ALCON GRIESHABER AG NA ASKU 07612717012233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other