BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO

    MDR report key: 12362362 · Received August 24, 2021

    Report

    Report Number
    2020664-2021-07173
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    July 8, 2021
    Report Date
    October 21, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HMX
    UDI-DI
    05050474521070
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 - LOT NUMBER 113455 AND UDI (B)(4). D9. RETURNED TO MANUFACTURER ON: OCTOBER 21, 2021. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6: INVESTIGATION CODES: 10, 3331. H6: INVESTIGATION FINDINGS: 115. H6: INVESTIGATION FINDINGS: 61. DEVICE EVALUATION: ACCOUNT REPORTED 1 EVENT HOWEVER THERE WERE 2 DEVICES RETURNED. BOTH DEVICES WERE EVALUATED. THIS IS THE FIRST COMPLAINT FOR THIS LOT. ONE OF THE DEVICES IS BENT AT THE BASE OF THE CANNULA. THE PORT WAS VISIBLY CLOGGED. THE PORT WAS ALSO DAMAGED WITH MULTIPLE GOUGES ON THE EDGES. THE PORT ON THE SECOND DEVICE WAS ALSO DAMAGED. THERE WAS A DENT/CRACK AT THE DISTAL END OF THE PORT. IT'S OBVIOUS ON BOTH DEVICES THAT SOMETHING HAS BEEN FORCED INTO THE PORT SO MUCH SO THAT IT HAS INDENTED THE CANNULAS AND CREATED A BURR ON THE PORT OF ONE DEVICE AND A CRACK ON THE EDGE OF THE PORT ON THE OTHER. IT IS POSSIBLE THAT IF THE DEVICE WAS NOT CLEANED AFTER SURGERY IT COULD LEAD TO CORTICAL MATERIAL HARDENING IN THE CANNULA AND THE PORT. IT IS ALSO POSSIBLE THAT THE DAMAGE OBSERVED WAS CAUSED IN AN ATTEMPT TO UNCLOG THE HANDPIECE AND THE PORT. THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE FOR DAMAGE. THE HANDLES SHOULD BE SOAKED IN STERILE DISTILLED WATER IMMEDIATELY AFTER USE PER INSTRUCTIONS IN THE DIRECTIONS FOR USE. THE OBSERVATIONS MADE INDICATE MISHANDLING OF DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE MEDICAL DEVICE PROBLEM CODE(S) 4013 WAS NOT INCLUDED, THE HEALTH EFFECT IMPACT CODE 4632 WAS NOT INCLUDED AND THE COMPONENT CODES 4755 AND 3067 WERE NOT INCLUDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PHONE #: (B)(6). LOT#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. DEVICE HAS NOT RETURNED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POSTERIOR CAPSULE RAPTURE OCCURRED WHILE SURGEON WAS POLISHING WITH THE IRRIGATION/ASPIRATION HANDPIECE DURING PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALLEGED THAT THE HANDPIECE TIP MIGHT HAVE HAD BURRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258580 SOLO CANNULA, OPHTHALMIC HMX JOHNSON & JOHNSON SURGICAL VISION, INC. OPOIA20STR 113455 05050474521070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention