{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220499",
      "product_res_number": "Z-2509-2026",
      "event_date_initiated": "2026-04-20",
      "event_date_posted": "2026-06-18",
      "recall_status": "Open, Classified",
      "res_event_number": "99007",
      "product_code": "MTA",
      "pma_numbers": [
        "P030016S027"
      ],
      "product_description": "Product Name: STAAR ICL Calculation Software\r\nSoftware Version: Version 8.00\r\nProduct Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment.\r\n\r\nNote: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication.\r\nComponent: No",
      "code_info": "Lot Code: UDI  (01)00840311346288(0812)8.00 \rSoftware Version 8.00\r\rThe software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.",
      "firm_fei_number": "3002808259",
      "recalling_firm": "Staar Surgical AG",
      "address_1": "Haupt Strasse 104 104 haupt strasse",
      "city": "Nidau",
      "country": "Switzerland",
      "additional_info_contact": "Philip Tsung\n626-3037902 Ext. 2263",
      "reason_for_recall": "Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.",
      "root_cause_description": "Software design",
      "action": "On 04/20/2026, the firm sent via FedEx an \"URGENT: MEDICAL DEVICE RECALL\" Letter informing customers that STAAR has confirmed that during that period, the printing of the IOD within the Stella Patient View, Order Confirmation, or Shopping Cart, when performed locally (i.e. by doctor/clinic), was under certain circumstances producing an incorrect diagram. The incorrect diagram was produced in certain circumstances when users created multiple Toric lens line items with different axis values on the same patient eye, such as with backup or secondary lens reservations.\n\nThe root cause has been identified as a software coding error in Stella 2.0 that did not assign a unique identifier to each reservation under a patient s eye. STAAR has modified the software code to assign a unique identifier, thereby preventing this issue when multiple reservations exist. Any IOD printed from Stella 2.0 after 5:30pm PDT on April 16, 2026 would not have been affected by this issue.\n\nFor Customer's awareness:\nWe are informing you so that a proper clinical decision can be made regarding patient management and follow-up, based on your assessment of the clinical outcome.\nPlease immediately complete and return the Recall Response Form acknowledging receipt of this recall and report any adverse events associated with this event.\nIf a Toric EVO/EVO+ device were implanted using an incorrect IOD printout, there is the potential for the following adverse events:\n\" Refractive surprise\n\" Blurred vision\n\" Glares/Halos\n\" Other visual disturbances\nRepositioning or removal of the lens may need to be considered in these cases.\n\nFor Questions - contact STAAR Sales Representative or Customer Service at customerservice@staar.com or by phone at 1-800-352-7842 Monday through Friday, 6:00am to 5:00pm PDT.",
      "product_quantity": "543",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Austria, Australia, Belgium, Canada, Switzerland, Czech Republic, Germany Spain, Finland, France, Great Britain, Hong Kong, Ireland, Israel, India, Iran, Italy, Jordan, Korea, Kuwait, Kazakhstan, Morocco, Malaysia, Netherlands, Oman, Philippines, Poland, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Ukraine, USA, Vietnam.",
      "openfda": {
        "pma_number": [
          "P030016",
          "P030028"
        ],
        "registration_number": [
          "3014173684",
          "3005941719",
          "2023826",
          "9614429",
          "8040449"
        ],
        "fei_number": [
          "3002501070",
          "3014173684",
          "3002807111",
          "3002808259",
          "2023826"
        ],
        "device_name": "Lens, Intraocular, Phakic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}