{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "MW5094271",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200424",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20171109",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "462378",
          "implant_date_year": "2017",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200424",
          "brand_name": "ACRYSOF IQ RESTOR MULTIFOCAL LENS",
          "generic_name": "LENS, MULTIFOCAL INTRAOCULAR",
          "manufacturer_d_name": "ALCON RESEARCH, LLC",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "MFK",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Lens, Multifocal Intraocular",
            "medical_specialty_description": "Ophthalmic",
            "regulation_number": "886.3600",
            "device_class": "3"
          }
        },
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "462379",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200424",
          "brand_name": "YAG CAPSULOTOMY",
          "generic_name": "POWERED LASER SURGICAL INSTRUMENT",
          "manufacturer_d_name": "UNK",
          "manufacturer_d_address_1": "UNK",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "UNK",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "GEX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Powered Laser Surgical Instrument",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "NY",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200424",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "62 YR",
          "patient_sex": "",
          "patient_weight": "70",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Visual Impairment",
            "Halo",
            "Visual Impairment",
            "Halo"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200423",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000821",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "189297435",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "VISION DISTURBANCES; HAD ACRYSOF IQ RESTOR LENS IMPLANTED IN BOTH EYES. HAD HALO TYPE VISION DISTURBANCES IMMEDIATELY (WHICH IS COMMON) BUT STILL HAVE THE SAME TO THIS DAY. HAD ANOTHER PROCEDURE DONE CALLED YAG CAPSULOTOMY AND NOW HAVE STREAKS AT NIGHT IN THE VISION FOR BOTH EYES. FDA SAFETY REPORT ID# (B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}