{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Dublin",
      "address_1": "5160 Hacienda Dr",
      "reason_for_recall": "VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue.  In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment.  Suction loss can occur in phase 1 through phase 5.  The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only.  The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.",
      "address_2": "",
      "product_quantity": "66 units",
      "code_info": "Serial Numbers:    988123   988132   1008162   1008173   1021446   1080079   1089462   1089463   1105752   1105765   1105766   1105773   1115905   1115920   1115926   1124475   1124476   1124478   1124480   1124483   1136403   1143784   1143795   1154532   1154534   1156046   1156048   1156053   1156059   1157773   1159423   1159430   1161751   1161753   1161756   1161763   1161764   1161765   1164588   1165541   1165545   1165548   1165550   1165552   1165553   1165554   1165555   1165562   1165563   1165565   1168236   1168239   1168243   1168244   1168245   1168246   1168254   1171082   1173826   1173832   1173838   1182193  1182194  1182195  1182196  1182198  1186711  1186713  1192911  1192914  1196018",
      "center_classification_date": "20191213",
      "distribution_pattern": "US nationwide distribution.",
      "state": "CA",
      "product_description": "VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction.    Catalog Number 0000000-1345-518    Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.",
      "report_date": "20191225",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Carl Zeiss Meditec, Inc.",
      "recall_number": "Z-0680-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "83913",
      "termination_date": "20210202",
      "more_code_info": "",
      "recall_initiation_date": "20181206",
      "postal_code": "94568-7562",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}