{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Milpitas",
      "address_1": "510 Cottonwood Dr",
      "reason_for_recall": "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.",
      "address_2": "",
      "product_quantity": "9",
      "code_info": "Model: Catalys Precision Laser System, CE 0044:    Catalys-U (US version)  Serial Numbers:  44065613 - software cOS 5.00.33 install date 4/27/2018  46131618 - software cOS 5.00.33 install date 4/23/2018  46131418 - software cOS 5.00.33 install date 4/30/2018  44107315 - software cOS 5.00.33 install date 5/1/2018  46120916 - software cOS 5.00.33 install date 4/23/2018  46123116 - software cOS 5.00.33 install date 5/2/2018  44106215 - software cOS 5.00.33 install date 5/3/2018    Catalys-I (International version)  Serial Number:  44109015 - software cOS 5.00.33 install date 5/1/2018  46124617 - software cOS 5.00.33 install date 5/3/2018",
      "center_classification_date": "20181003",
      "distribution_pattern": "US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.",
      "state": "CA",
      "product_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.",
      "report_date": "20181010",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Johnson & Johnson Surgical Vision Inc",
      "recall_number": "Z-0066-2019",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "80849",
      "termination_date": "20210113",
      "more_code_info": "",
      "recall_initiation_date": "20180509",
      "postal_code": "95035-7403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}