{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121966",
      "product_res_number": "Z-0047-2014",
      "event_date_initiated": "2013-09-16",
      "event_date_posted": "2013-10-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-11-12",
      "res_event_number": "66304",
      "product_code": "LZS",
      "pma_numbers": [
        "P930016S011"
      ],
      "product_description": "STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA\n\nThe STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.",
      "code_info": "All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.",
      "firm_fei_number": "3006695864",
      "recalling_firm": "Abbott Medical Optics, Inc.",
      "address_1": "510 Cottonwood Dr",
      "city": "Milpitas",
      "state": "CA",
      "postal_code": "95035-7403",
      "additional_info_contact": "Christopher Carnahan\n408-273-4100",
      "reason_for_recall": "This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, Abbott Medical Optics, Inc., (AMO), sent an \"ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE\" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff.\n\nIf you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.",
      "product_quantity": "834 units in total",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.",
      "openfda": {
        "pma_number": [
          "P020050",
          "P970056",
          "P990027",
          "P030008",
          "P930034",
          "P980008",
          "P990010",
          "P910067",
          "P970005",
          "P960019",
          "P910062",
          "P970043",
          "P930016",
          "P970053",
          "P060004"
        ],
        "registration_number": [
          "3006695864",
          "2936921",
          "3038356864",
          "9615030",
          "8030392",
          "3007606649",
          "3012236936",
          "3002807715",
          "3003288808",
          "1920664",
          "9710340"
        ],
        "fei_number": [
          "3006695864",
          "2936921",
          "3003691824",
          "3038356864",
          "3002483854",
          "3012236936",
          "3002807715",
          "3001362763",
          "3003288808",
          "1920664"
        ],
        "device_name": "Excimer Laser System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}