BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25G X 7/8¿ VISCOELASTIC

    MDR report key: 12158622 · Received July 13, 2021

    Report

    Report Number
    0001920664-2021-00084
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    May 17, 2021
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D3: MANUFACTURE NAME: BAUSCH + LOMB REPORTED IN ERROR. CORRECTED MANUFACTURE NAME: STERIMEDIX LIMITED, CITY: ROCHESTER REPORTED IN ERROR. CORRECTED CITY: REDDITCH, STATE REMOVED, COUNTRY: UNITED STATES (USA) REPORTED IN ERROR. CORRECTED COUNTRY: UNITED KINGDOM (GBR), POSTAL CODE (ZIP): 14609 REPORTED IN ERROR. CORRECTED POSTAL CODE (ZIP): B98 9ND. H10: NARRATIVE/CORRECTED DATA: (REPORT 4 OF 8; SEE ALSO 0001920664-2021-00081, 0001920664-2021-00082, 0001920664-2021-00083,0001920664-2021-00085, 0001920664-2021-00086, 0001920664-2021-00095, 0001920664-2021-00096) REPORTED IN ERROR. CORRECTED NARRATIVE/CORRECTED DATA: (REPORT 4 OF 6; SEE ALSO 0001920664-2021-00081, 0001920664-2021-00082, 0001920664-2021-00083, 0001920664-2021-00085, 0001920664-2021-00086). (REPORT 4 OF 6; SEE ALSO 0001920664-2021-00081, 0001920664-2021-00082, 0001920664-2021-00083, 0001920664-2021-00085, 0001920664-2021-00086).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND THE PACKAGING WAS EVALUATED BY BUBBLE EMISSION TESTING AND MICROBIOLOGY/STERILITY TESTING. THE RETURNED PRODUCT PASSED ALL BUBBLE EMISSION TESTS AND NO OBSERVATIONS WERE NOTED INDICATING THE PACKAGING INTEGRITY HAD NOT BEEN COMPROMISED. THE RETURNED PRODUCT PASSED ALL MICROBIOLOGY/STERILITY TESTING POST STERILIZATION WITH NO MICROBIOLOGICAL GROWTH AND NO OBSERVATIONS NOTED. SINCE THE REPORTED PROBLEM COULD NOT BE DUPLICATED WE HAVE CONCLUDED THAT THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION IS COMPLETE. (REPORT 4 OF 8; SEE ALSO 0001920664-2021-00081, 0001920664-2021-00082, 0001920664-2021-00083, 0001920664-2021-00085, 0001920664-2021-00086, 0001920664-2021-00095, 0001920664-2021-00096).

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED BY THE CUSTOMER BUT THE PRODUCT EVALUATION IS NOT YET COMPLETE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. A CAPA WAS INITIATED. THE INVESTIGATION IS ONGOING. (REPORT 4 OF 6; SEE ALSO 0001920664-2021-00081, 0001920664-2021-00082, 0001920664-2021-00083, 0001920664-2021-00085, 0001920664-2021-00086).

    Description of Event or Problem · 1

    A FACILITY IN (B)(6) REPORTED A CLOUDY VIEW OR HAZINESS ON THE EYE WHEN INJECTING THE VISCOELASTIC WHICH OBSTRUCTED THE SURGEON'S VIEW. IN SOME PROCEDURES, A NEW SYRINGE WAS USED TO COMPLETE THE SURGERY. SOME PROCEDURES WERE PROLONGED BY 20-40 MINUTES AND, IN SOME OF THOSE CASES, THE SURGEON MAY HAVE USED ADDITIONAL ANESTHESIA. NO PATIENT IMPACT OR MEDICAL INTERVENTION WAS REPORTED. CURRENTLY, THE PATIENTS SEEM OKAY WITH NO POST-OP COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056815 25G X 7/8¿ VISCOELASTIC CANNULA, OPHTHALMIC HMX 2639A-02S 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention