{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "169984",
      "product_res_number": "Z-0865-2019",
      "event_date_initiated": "2018-11-13",
      "event_date_posted": "2019-03-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-03-14",
      "res_event_number": "81812",
      "product_code": "LQE",
      "pma_numbers": [
        "P150034"
      ],
      "product_description": "Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.",
      "code_info": "All lots of unused product",
      "firm_fei_number": "3015045165",
      "recalling_firm": "RVO 2.0, INC",
      "address_1": "26800 Aliso Viejo Pkwy",
      "address_2": "Ste 160",
      "city": "Aliso Viejo",
      "state": "CA",
      "postal_code": "92656-2625",
      "additional_info_contact": "720-350-8850",
      "reason_for_recall": "During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 11/13/2018, the firm started emailing Urgent Medical Device Recall notices and acknowledgment forms to consignees. This recall notice was intended for 1) patients implanted with the Raindrop Inlay and 2) eye care providers. Eye care providers were asked to cease further implantation and to return unused affected devices to the recalling firm. Eye care providers were informed that patients implanted with affected devices should continue to see their eye care providers on a regular basis, preferably every 6-months and no less often than every 12 months. Also, patients who have had their devices explanted should maintain a follow-up schedule with their provider. The firm commits to physicians to support the patient's best interests and to continue the FDA post approval study to monitor the device's ongoing performance and safety.  The firm requests that all consignees complete and return, acknowledgement forms, regardless of whether they do or do not have unused affected product to return.  Acknowledgement forms should be returned via email to Jennifer.Luong@opticsmedical.com.  Customers with questions are encouraged to call 949-330-6511.",
      "product_quantity": "2869",
      "distribution_pattern": "U.S.: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA;\n\nNo OUS (Foreign) Distribution.",
      "openfda": {
        "pma_number": [
          "P150034",
          "P120023",
          "P980031"
        ],
        "device_name": "Implant, Corneal, Refractive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3002224346",
          "2024311",
          "2953726"
        ],
        "fei_number": [
          "3002224346",
          "2024311",
          "3000309468"
        ]
      }
    }
  ]
}