{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Port",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79379",
      "recalling_firm": "SIE AG, Surgical Instrument Engineering",
      "address_1": "Allmendstrasse 11",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AL, CA, FL, GA, IL, IN, MN, OR, TN, TX, VA, and WA; and countries of: Argentina, Austria, Belgium, Brazil, Canada, France, Germany, India, Iraq, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Namibia, Pakistan, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Spain, South Africa, Switzerland, Taiwan, and United Arab Emirates.",
      "recall_number": "Z-1272-2018",
      "product_description": "The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser      The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.",
      "product_quantity": "125 devices",
      "reason_for_recall": "This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure.  An investigation completed by the manufacturer determined that although the complication was due to user error improvements could and should be made on our part to improve the usability and performance of our device.",
      "recall_initiation_date": "20180121",
      "center_classification_date": "20180329",
      "termination_date": "20181102",
      "report_date": "20180404",
      "code_info": "Serial Numbers:    FLM4455  FLM2313  FLM4499  FLM3230  FLM2855  FLM3097  FLM4493  FLM3178  FLM4441  FLM1592  FLM2595  FLM1225  FLM4542  FLM3771  FLM1464  FLM3999  FLM2408  FLM1995  FLM4409  FLM2185  FLM2679  FLM4987  FLM3815  FLM3904  FLM1958  FLM1179  FLM2869  FLM2584  FLM4860  FLM3766  FLM2318  FLM3406  FLM4626  FLM2324  FLM1326  FLM2053  FLM2096  FLM4222  FLM4450  FLM2266  FLM4588  FLM4175  FLM4764  FLM4902  FLM4227  FLM2457  FLM1767  FLM4132  FLM4896  FLM3007  FLM1274  FLM1009  FLM1320  FLM2537  FLM3278  FLM2508  FLM3905  FLM4043  FLM4133  FLM4314  FLM1819  FLM2186  FLM3135  FLM2627  FLM4271  FLM1092  FLM4759  FLM1724  FLM2589  FLM4770  FLM2038  FLM1188  FLM1640  FLM1915  FLM4317  FLM1814  FLM2812  FLM1003  FLM4859  FLM1135  FLM4807  FLM1502  FLM3183  FLM1182  FLM4954  FLM4000  FLM4531  FLM2551  FLM1554  FLM3539  FLM1046  FLM2765  FLM4897  FLM2913  FLM1093  FLM4632  FLM1686  FLM2912  FLM1782  FLM1545  FLM3359  FLM4908  FLM2085  FLM1407  FLM1863  FLM4308  FLM3677  FLM2636  FLM1008  FLM4361  FLM4669  FLM4498  FLM3729  FLM1773  FLM1364  FLM1591  FLM1824  FLM2229  FLM2450  FLM2722  FLM3676  FLM3861  FLM4593  FLM3040  FLM2001",
      "more_code_info": ""
    }
  ]
}