{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "201305", "product_res_number": "Z-1971-2023", "event_date_initiated": "2023-03-16", "event_date_posted": "2023-06-27", "recall_status": "Open, Classified", "res_event_number": "92532", "product_code": "HQF", "k_numbers": [ "K081565", "K142398" ], "product_description": "Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532\nSpare, Optics Bench V2, L2G/LP6G", "code_info": "Serial Nos., UDI\nIPY0374,\n(01) 0 9342395 00012 0\nISRY0242,\n(01) 0 9342395 00015 1\nISG0370,\n(01) 0 9342395 00024 3\nIPG0539,\n(01) 0 9342395 00009 0\nBG1190", "firm_fei_number": "3002806902", "recalling_firm": "Ellex Medical Pty Ltd.", "address_1": "3-4 Second Ave", "city": "Lakes", "state": "Mawson", "country": "Australia", "additional_info_contact": "Richard Knapczyk\n952-767-5781", "reason_for_recall": "When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.", "root_cause_description": "Radiation Control for Health and Safety Act", "action": "Ellex Safety Bulletin is the customer notification letter. Ellex will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Ellex-Lumibird representative or email us on eservice@ellex.com.", "product_quantity": "57 systems in total (6 units shipped to United States)", "distribution_pattern": "US nationwide/ Worldwide Distribution", "openfda": { "k_number": [ "K112154", "K844668", "K051944", "K905141", "K833274", "K142172", "K043613", "K142830", "K170067", "K874609", "K942180", "K895213", "K230228", "K203130", "K926470", "K852464", "K973193", "K833232", "K791659", "K910805", "K875000", "K852529", "K240615", "K043236", "K123542", "K870839", "K130195", "K230722", "K850572", "K812219", "K192045", "K832316", "K103056", "K152688", "K181682", "K100019", "K862568", "K001772", "K232051", "K960522", "K220877", "K021538", "K840590", "K133019", "K863246", "K905453", "K153769", "K010372", "K952894", "K031023", "K251507", "K841856", "K124043", "K843965", "K881134", "K111643", "K890509", "K873460", "K232417", "K981196", "K854288", "K050807", "K881494", "K201502", "K972514", "K050541", "K925663", "K834610", "K142398", "K222395", "K833532", "K782106", "K081565", "K040209", "K900199", "K063297", "K833533", "K230350", "K813492", "K090774", "K201623", "K894273", "K854949", "K903421", "K140336", "K020374", "K834305", "K223132", "K061024", "K781965", "K904366", "K121187", "K212630", "K130933", "K091581", "K844358", "K841855", "K103547", "K070776", "K220430", "K904699", "K882372", "K894835", "K180402", "K213592", "K893630", "K910612", "K860358", "K190448", "K931784", "K862987", "K092621", "K152603", "K242397", "K801336", "K140362", "K872846", "K120825", "K013760", "K123056", "K935747", "K222157", "K131207", "K231011", "K062624", "K842250", "K111460", "K782065", "K844357", "K072823", "K080423", "K091981", "K202760", "K252979", "K864063", "K081774", "K842251", "K883213", "K973220", "K971950", "K133358", "K122202", "K842412", "K910532", "K852234", "K832089", "K251772", "K041598", "K990075", "K893709", "K960971", "K243014", "K932836", "K840854", "K840145", "K951079", "K091064", "K220974", "K895196", "K853890", "K031665", "K233911", "K091534", "K100253", "K890086", "K111108", "K834060", "K062074", "K863591", "K033941", "K170302", "K882908", "K081946", "K190083", "K885164", "K990665", "K932296", "K023094", "K171488", "K964751" ], "pma_number": [ "P990078" ], "registration_number": [ "", "9615745", "3004467263", "3009462521", "8043792", "3029221947", "3009298127", "3020611964", "8030988", "3002807715", "3005941719", "3013515803", "3012037425", "3005350457", "3038356864", "3002808022", "2246552", "3027683457", "3010208880", "1018470", "3010849408", "3004858034", "3004497289", "3010487482", "2031962", "2529392", "9611516", "1000391004", "1928237", "1644019", "3008252121", "3009026057", "2028159", "8030392", "3002807090", "3005012805", "3045817901", "3016405041", "1650907", "3030860039", "9680671", "3008156177", "2936921", "1920664", "3007589150", "1932180", "1054713", "3001592626", "2247224", "1047843", "1222616", "3009337401", "9681121", "1313525", "3015658550", "2939653", "3002991496", "1526711", "1211998", "3016678045", "3010220595", "3007851054", "9615030" ], "fei_number": [ "", "3004467263", "3009462521", "3029221947", "1000122089", "3009298127", "1317628", "3002807715", "3003465293", "1000121498", "3012037425", "3000314405", "3005350457", "3038356864", "3002807944", "3002808022", "3002808269", "2246552", "3010208880", "1018470", "3003282815", "3010849408", "3004858034", "1000119305", "1000117501", "3010487482", "3027683457", "3004497289", "3002445546", "1000391004", "1000120916", "1928237", "3001362763", "3008252121", "3009026057", "3002681132", "1000125771", "3002806863", "3005012805", "3045817901", "3016405041", "3030860039", "3003559308", "2936921", "1920664", "3007589150", "3002807111", "3001592626", "1047843", "3009337401", "3006003617", "3015658550", "1720381", "2939653", "3002991496", "3002806902", "1526711", "1211998", "3016678045", "3010220595", "3007851054", "1000114111" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }