BEUDAMED
    FDA Recall Terminated

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    Recall: Z-0066-2019 · Initiated May 9, 2018

    Recall

    Recall Number
    Z-0066-2019
    Event Number
    80849
    Firm
    Johnson & Johnson Surgical Vision Inc
    FEI Number
    3006695864
    Product Code
    OOE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 9, 2018
    Terminated
    January 13, 2021
    Address
    510 Cottonwood Dr, Milpitas, CA, 95035-7403

    Description

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    Reason

    Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.

    Action

    On May 9, 2018, affected customers in the U.S. and Puerto Rico were contacted by phone and verbally informed to stop using the affected system. On May 22, 2018, the firm, Johnson & Johnson Vision, sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated May 18, 2018 via Federal Express overnight delivery with signature required to all customers with a system containing the affected software installed. The customers were instructed to: STOP Using the affected system and complete and return the Customer Reply Form via fax to: Johnson & Johnson Vision Quality Assurance at 1-714-247-4510, emailed to [email protected], or provide to your Johnson & Johnson Vision Representative within 3 business days of receipt of the letter. The firm will coordinate the removal of the affected software for all affected systems. All impacted customers will be provided with the new/updated software version. If you have any questions, contact the Director, Quality Assurance at 408-273-4100 or email: [email protected].

    Distribution

    US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.

    Quantity

    9