{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187983", "product_res_number": "Z-2097-2021", "event_date_initiated": "2021-04-14", "event_date_created": "2021-07-20", "recall_status": "Open, Classified", "res_event_number": "88146", "product_code": "HQF", "k_numbers": [ "K031023" ], "product_description": "Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system\nProduct Code: 7510.ALC", "code_info": "Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122", "firm_fei_number": "3007916166", "recalling_firm": "Dutch Ophthalmic USA, Inc.", "address_1": "10 Continental Dr Bldg 1 10 Continental Dr", "address_2": "Bldg 1", "city": "Exeter", "state": "NH", "postal_code": "03833-7507", "additional_info_contact": "SAME\n603-778-6929", "reason_for_recall": "Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01", "root_cause_description": "Process control", "action": "Dutch Ophthalmic issued Urgent Medical Device Recall letter on 4/14/21 via Certified Mail. Letter states reason for recall, health risk and action to take:\nVerify whether you have unused boxes of LOT 039406 in your inventory and\nquarantine product subject to this safety notice.\n\" If returned contact Customer Service at Dutch Ophthalmic, USA at 1-800-753-\n8824 x 1 to receive a Return Material Authorization (RMA) number and receive\ninstructions on how to return unused boxes of the impacted product.\n\" If not returning, verify that expiry dates in any hospital system are showing the\ncorrect expiry date of 2024- 10-01. If not, please ensure the expiry date is\nmodified to reflect the actual expiry date.\n\" For opened boxes of LOT 039406, verify that expiry dates in any hospital system are showing the correct expiry date of 2024-10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date.\n\nComplete the attached Urgent Medical Device Safety Notice Reconciliation Form, sign it and return a scan or photo of the signed form by email to\nd.clement@dorcglobal.com.\n\" Add the original completed and signed Urgent Medical Device Safety Notice\nReconciliation Form referencing the Return Material Authorization number with the product to be returned.\n\nIn the next days our sales representative will contact you to discuss replacement of the to be returned boxes and to verify whether there are additional questions or actions in which we can assist. If in the meantime you need any further information or support concerning this issue, please contact our local representative at Dutch Ophthalmic USA at 1-800-753-8824 x 1 for assistance.", "product_quantity": "13 Boxes", "distribution_pattern": "Nationwide Distribution in the states of CA, FL, MA, and UT.", "openfda": { "k_number": [ "K153769", "K813492", "K031665", "K862987", "K100019", "K864063", "K931784", "K202760", "K952894", "K925663", "K893709", "K091534", "K951079", "K223132", "K875000", "K932836", "K881494", "K932296", "K051944", "K972514", "K240615", "K874609", "K180402", "K112154", "K231011", "K212630", "K910805", "K090774", "K213592", "K170067", "K812219", "K120825", "K171488", "K882908", "K873460", "K832316", "K122202", "K232417", "K133019", "K243014", "K883213", "K091981", "K860358", "K890509", "K050541", "K981196", "K840590", "K092621", "K103056", "K152603", "K111643", "K220974", "K870839", "K960971", "K894273", "K232051", "K834610", "K031023", "K872846", "K201623", "K170302", "K990665", "K890086", "K832089", "K111460", "K842412", "K091064", "K230722", "K844668", "K201502", "K833274", "K023094", "K852464", "K882372", "K844357", "K043236", "K043613", "K190083", "K010372", "K192045", "K841856", "K091581", "K791659", "K123056", "K080423", "K142172", "K111108", "K033941", "K190448", "K233911", "K852234", "K242397", "K061024", "K152688", "K844358", "K894835", "K960522", "K140362", "K903421", "K935747", "K181682", "K130195", "K905141", "K964751", "K863591", "K801336", "K895213", "K850572", "K900199", "K081565", "K203130", "K130933", "K222157", "K895196", "K893630", "K081774", "K990075", "K842250", "K062624", "K973193", "K001772", "K782065", "K833532", "K220430", "K070776", "K142830", "K834305", "K840145", "K942180", "K133358", "K142398", "K123542", "K843965", "K833232", "K904699", "K041598", "K072823", "K852529", "K121187", "K230228", "K881134", "K252979", "K971950", "K854949", "K062074", "K081946", "K220877", "K222395", "K021538", "K853890", "K131207", "K100253", "K862568", "K050807", "K840854", "K842251", "K781965", "K885164", "K230350", "K910612", "K926470", "K782106", "K904366", "K834060", "K103547", "K251507", "K140336", "K863246", "K973220", "K020374", "K013760", "K251772", "K910532", "K905453", "K833533", "K841855", "K124043", "K854288", "K040209", "K063297" ], "pma_number": [ "P990078" ], "registration_number": [ "3002991496", "1650907", "", "3009026057", "2939653", "9615745", "8030988", "3002807715", "9681121", "3016678045", "3027683457", "3010487482", "3001592626", "3045817901", "1054713", "3010220595", "1920664", "3005350457", "2247224", "3015658550", "3008156177", "1222616", "1526711", "2529392", "2246552", "9615030", "3029221947", "3012037425", "1047843", "2028159", "3010208880", "3007851054", "1928237", "1644019", "1211998", "1932180", "3009337401", "3004467263", "3030860039", "3004858034", "3002808022", "2936921", "3038356864", "3007589150", "2031962", "3005012805", "3016405041", "3005941719", "3002807090", "3010849408", "1313525", "9611516", "3013515803", "3008252121", "3009462521", "1018470", "3004497289", "9680671", "3009298127", "3020611964", "8030392", "1000391004", "8043792" ], "fei_number": [ "3003282815", "3002991496", "3002808269", "3009026057", "", "2939653", "3001592626", "3002807715", "3016678045", "3002806863", "3027683457", "3010487482", "3045817901", "3001362763", "3003559308", "3010220595", "1920664", "3003465293", "3002807111", "3005350457", "3015658550", "3006003617", "1526711", "1000117501", "3002806902", "2246552", "3029221947", "1000119305", "3012037425", "3000314405", "1720381", "1047843", "1000121498", "1000120916", "3010208880", "3007851054", "3002681132", "1928237", "1211998", "1000114111", "3030860039", "3009337401", "3004467263", "1000122089", "3002445546", "3004858034", "3002808022", "2936921", "3038356864", "3007589150", "3005012805", "3016405041", "3010849408", "3008252121", "3009462521", "1018470", "3004497289", "3002807944", "3009298127", "1000125771", "1317628", "1000391004" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }