{
  "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,
      "limit": 1,
      "total": 41218
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "2028159-2008-00062",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080213",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20080114",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Health Professional",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080422",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080213",
          "brand_name": "INFINITI VISION SYSTEM",
          "generic_name": "OPHTHALMIC SURGERY SYSTEM",
          "manufacturer_d_name": "ALCON - IRVINE TECHNOLOGY CENTER",
          "manufacturer_d_address_1": "15800 ALTON PKWY.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "IRVINE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92618",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92618",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "INFINITI",
          "catalog_number": "8065750180",
          "lot_number": "NA",
          "other_id_number": "NA",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20080121",
          "device_report_product_code": "HQC",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "2028159"
            ],
            "fei_number": [
              "1000125771"
            ],
            "device_name": "Unit, Phacofragmentation",
            "medical_specialty_description": "Ophthalmic",
            "regulation_number": "886.4670",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "No Display/Image"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250805",
      "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": "20080213",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NI",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Surgical procedure, delayed"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080114",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1000516",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080114",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer 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": "794713",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE CUSTOMER REPORTED, THE SYS SCREEN WOULD NOT DISPLAY DURING SET UP. THE PT HAD REC'D DILATING DROPS, BUT WAS NOT YET IN THE OPERATING ROOM. THE CASE WAS CANCELLED. THERE WAS NO PT INJURY."
        },
        {
          "mdr_text_key": "7934684",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE CUSTOMER SVC REP EXAMINED THE SYS AND FOUND THE HOST POWER PCB CAUSED THE REPORTED ISSUE. THE HOST POWER PCB WAS REPLACED AND SENT FOR IN HOUSE TESTING. THE SYS WAS CHECKED AND MET ALL PROD SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON 02/13/2008."
        }
      ],
      "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": ""
    }
  ]
}