{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203884",
      "product_res_number": "Z-0464-2024",
      "event_date_initiated": "2023-09-29",
      "event_date_posted": "2023-12-01",
      "recall_status": "Open, Classified",
      "res_event_number": "93312",
      "product_code": "MTA",
      "pma_numbers": [
        "P030016"
      ],
      "product_description": "EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1.  Phakic Intraocular lens.",
      "code_info": "Serial/UDI:\n\nS1894967/(01)00841542118965(11)230330(17)250228(21)S1894967;\nS1954863/(01)00841542118958(11)230513(17)250430(21)S1954863;\nS1725689/(01)00841542118910(11)221103(17)241031(21)S1725689;\nS1725624/(01)00841542118873(11)221103(17)241031(21)S1725624;\nS1771602/(01)00841542118927(11)221214(17)241130(21)S1771602;\nS1725625/(01)00841542118873(11)221103(17)241031(21)S1725625;\nS1847793/(01)00841542119030(11)230218(17)250131(21)S1847793;\nS1725627/(01)00841542118873(11)221103(17)241031(21)S1725627;\nS1901889/(01)00841542118873(11)230404(17)250331(21)S1901889;\nS1771554/(01)00841542118873(11)221214(17)241130(21)S1771554;\nS1699274/(01)00841542118972(11)221016(17)240930(21)S1699274;\nS1877126/(01)00841542118965(11)230313(17)250228(21)S1877126;\nS1771633/(01)00841542119030(11)221214(17)241130(21)S1771633;\nS1744475/(01)00841542118910(11)221119(17)241031(21)S1744475;\nS1863018/(01)00841542118873(11)230302(17)250228(21)S1863018;\nS1734365/(01)00841542118934(11)221112(17)241031(21)S1734365;\nS1877112/(01)00841542118965(11)230313(17)250228(21)S1877112;\nS1901884/(01)00841542118873(11)230404(17)250331(21)S1901884;\nS1725691/(01)00841542118910(11)221103(17)241031(21)S1725691;\nS1892278/(01)00841542118897(11)230328(17)250228(21)S1892278",
      "firm_fei_number": "2023826",
      "recalling_firm": "Staar Surgical Company",
      "address_1": "1911 Walker Ave",
      "city": "Monrovia",
      "state": "CA",
      "postal_code": "91016-4846",
      "additional_info_contact": "STAAR Customer Service\n800-352-7842 Ext. 2271",
      "reason_for_recall": "Their is a potential that intraocular implant devices may not meet specifications.",
      "root_cause_description": "Software design (manufacturing process)",
      "action": "On October 25, 2023, Staar Surgical issued a \"Urgent: Medical Device Voluntary Recall\" notification to affected consignees.  Staar Surgical ask consignees to take the following actions: \n\n1. Review your current inventory of STAAR EVO/EVO+ devices.\n\n2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the\nproduct.\n3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession.\n4. Fax the form within 5 days upon receipt of this notification to: 1-800-952-4923 or email a pdf copy of the form to: atramontana@staar.com.\n5. Return the EVO/EVO+ device(s) with the Medical Device Recall Return Response form to\nSTAAR Surgical using the prepaid postage to the address identified in the attached Medical\nDevice Recall Return Response form.\n6. Apply the enclosed sticker/label \"Attn: Recall Coordinator\" to the outside of each ICL box being returned to STAAR Surgical.\n7. Affected product and distribution information specific to your facility is contained in the Medical Device Recall Return Response Form",
      "product_quantity": "20 units",
      "distribution_pattern": "US: AR\tAZ\tCA\tCO\tCT\tFL\tGA\tHI\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tMI\tMN\tMO\tMT\tNC\tND\tNE\tNJ\tNV\tNY\tOH\tOK\tOR\tPA  SC\tSD\tTN\tTX\tUT\tVA\tWA\tWI\n\nOUS: None",
      "openfda": {
        "device_name": "Lens, Intraocular, Phakic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P030028",
          "P030016"
        ],
        "registration_number": [
          "8040449",
          "3014173684",
          "9614429",
          "3005941719",
          "2023826"
        ],
        "fei_number": [
          "3002501070",
          "3014173684",
          "3002807111",
          "3002808259",
          "2023826"
        ]
      }
    }
  ]
}