BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC

    MDR report key: 16425739 · Received February 23, 2023

    Report

    Report Number
    2523835-2023-00082
    Event Type
    Injury
    Date Received
    February 23, 2023
    Report Date
    April 20, 2023
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HMX
    UDI-DI
    00380651495258
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF RETINAL TEAR; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. LITERATURE ARTICLE: "OUTCOMES AND COMPLICATIONS OF RHEGMATOGENOUS RETINAL DETACHMENT REPAIR WITH SELECTIVE SUTURELESS 25-GAUGE PARS PLANA VITRECTOMY". (AMERICAN JOURNAL OF OPHTHALMOLOGY 2010:149 630¿634). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE FILE STATED ENLARGEMENT OF PREEXISTING RETINAL BREAK AND MILD TEMPORARY HEMORRHAGE OF THE PATIENTS' EYE DURING FLUID AIR EXCHANGE MODE. THE RETINAL BREAK REQUIRED ADDITIONAL LASER, SCLERAL SUTURES AND SCLEROTOMY. CURRENT CONDITION OF PATIENTS' WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575094 ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC CANNULA, OPHTHALMIC HMX ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU 00380651495258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O RETROBULBAR ANESTHETICS| SILICONE OIL