{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73896", "product_res_number": "Z-0274-2009", "event_date_initiated": "2008-09-26", "event_date_posted": "2008-11-06", "recall_status": "Terminated", "event_date_terminated": "2012-03-07", "res_event_number": "49600", "product_code": "HQF", "product_description": "PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 \n\nIndicated for use in photocoagulation of both anterior and posterior segments of the eye.", "code_info": "Serial Numbers 0801438901X, 0801481701X2, 0801591601X2, 0801591701X1, 0801591801X1, 0801692701X1, 0801717801X3, 0801717901X, 0801718001X1, 0801718101X, 0801718201X, 0801763401X1, 0801763601X, 0801817201X, 0801817601X, 0801844601X1, 0801844701X1, 0801844801X1, 0801844901X, 0801845001X1, 0801887201X, 0801887501X, 0801887601X, 0801965801X, 0801965901X, 0801966001X, 0802057301X, 0802057501X, 0802244501X, 0802244701X, 0802245101X, 0802480501X, 0802480901X, 0802484101X, 0802514101X, 0802529501X, 0802570101X, 0801887401X, 0802244301X, 0801439201X, and 0802244901X,", "firm_fei_number": "1000125771", "recalling_firm": "Alcon Laboratories, Inc.", "address_1": "15800 Alton Pkwy", "city": "Irvine", "state": "CA", "postal_code": "92618", "additional_info_contact": "949-753-1393", "reason_for_recall": "Alcon had identified that indications for use unapproved by the Food and Drug Administration are included in the PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Revision B.", "root_cause_description": "Employee error", "action": "An Alcon representative has been provided with a package of information for each customer site. All domestic customers are being provided an Urgent: Medical Device Correction letter describing the change to the PurePoint Operator's Manual and are being issued a revised PurePoint Operator's Manual (Revision C). The letter advises that Alcon Research, Ltd, has initiated a voluntary correction based upon unapproved indications for use identified within the Alcon PurePoint Laser System Operator's Manual, Revision B. The letter advises that the following indications for use have been updated or removed on page 1.14, Professional Operator's Information, in Revision C of the PurePoint Laser System Operator's Manual:\nUpdated:\n\"AMD; Wet or Dry to include macular degeneration\" has been updated to read \"Choroidal neovascularization secondary to age-related macular degeneration (AMD)\".\n\"Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG), Acute Angle Closure\nGlaucoma (AACG), and refractory glaucoma\" has been updated to read \"Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG, POAG) and refractory glaucoma\"\nRemoved:\nMacular photocoagulation; including grid, focal, laser drusen scatter (panretinal)\nTranscleral cyclophotocoagulation\nIntra-ocular tumors; to include choroidal hemangioma, choroidal melanoma, retinoblastoma\nOtosclerotic hearing loss. No other changes to the manual have been made in this revision and no other Alcon products are affected by this correction. Per the letter, an Alcon Representative will provide customers with a new PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev. C. and customers are return their existing PurePoint Laser System Operator's Manual, Catalog Number 8065751131, Rev.B. A signed confirmation of receipt of the letter is required from all customers.", "product_quantity": "41 units", "distribution_pattern": "Worldwide Distribution --- USA including states of IL, WI, TX, MI, PA, NY, CT, SC, NC, LA, FL, GA, CA, OR, WA, CO, and NV, and countries of India, Bulgaria, Barbados, and Dominican Republic.", "openfda": { "k_number": [ "K960971", "K041598", "K854949", "K862987", "K220877", "K895196", "K190448", "K842250", "K001772", "K834305", "K881494", "K232051", "K091064", "K051944", "K841856", "K133019", "K242397", "K031023", "K230350", "K883213", "K890509", "K842412", "K040209", "K894273", "K120825", "K251507", "K863591", "K130933", "K021538", "K031665", "K251772", "K860358", "K964751", "K895213", "K091581", "K832089", "K112154", "K973220", "K882372", "K853890", "K834610", "K844668", "K020374", "K882908", "K910532", "K131207", "K142830", "K873460", "K133358", "K885164", "K843965", "K091534", "K230722", "K243014", "K971950", "K981196", "K833232", "K201502", "K213592", "K223132", "K222395", "K904366", "K813492", "K123542", "K203130", "K874609", "K043236", "K850572", "K951079", "K063297", "K123056", "K081565", "K893630", "K894835", "K152688", "K023094", "K090774", "K854288", "K833533", "K153769", "K840854", "K932836", "K092621", "K010372", "K192045", "K791659", "K925663", "K910612", "K091981", "K841855", "K782065", "K231011", "K832316", "K781965", "K033941", "K935747", "K990075", "K233911", "K990665", "K844358", "K072823", "K932296", "K111460", "K833532", "K926470", "K852464", "K152603", "K081774", "K834060", "K220430", "K081946", "K842251", "K201623", "K212630", "K973193", "K893709", "K863246", "K904699", "K103547", "K840590", "K170302", "K061024", "K050541", "K220974", "K905453", "K840145", "K013760", "K942180", "K130195", "K931784", "K171488", "K903421", "K100253", "K190083", "K900199", "K952894", "K852234", "K232417", "K870839", "K122202", "K170067", "K230228", "K142398", "K844357", "K862568", "K801336", "K812219", "K872846", "K062074", "K240615", "K080423", "K222157", "K070776", "K100019", "K111643", "K050807", "K202760", "K103056", "K124043", "K180402", "K972514", "K852529", "K890086", "K960522", "K881134", "K910805", "K121187", "K062624", "K140362", "K864063", "K043613", "K140336", "K252979", "K181682", "K782106", "K142172", "K111108", "K833274", "K905141", "K875000" ], "pma_number": [ "P990078" ], "registration_number": [ "1211998", "3002808022", "9611516", "2247224", "3001592626", "9681121", "1932180", "8030988", "3007851054", "3008156177", "1313525", "1222616", "2031962", "3004467263", "3027683457", "3015658550", "3010220595", "3038356864", "2246552", "3010208880", "1047843", "2028159", "1000391004", "3020611964", "3009337401", "3002991496", "3029221947", "3004858034", "3016405041", "1928237", "3009462521", "1920664", "2936921", "3008252121", "9615745", "3004497289", "3002807090", "3045817901", "3013515803", "2529392", "3010849408", "3016678045", "3009026057", "3012037425", "9680671", "3009298127", "3002807715", "1018470", "8043792", "9615030", "1644019", "3005012805", "3005350457", "2939653", "1054713", "1650907", "3030860039", "8030392", "3010487482", "3007589150", "1526711", "3005941719" ], "fei_number": [ "1211998", "3002808022", "3002808269", "1000114111", "3001592626", "1720381", "3007851054", "3002807944", "3002445546", "3004467263", "3027683457", "3003465293", "3015658550", "3010220595", "3038356864", "2246552", "3010208880", "1047843", "1000391004", "3029221947", "3009337401", "3002991496", "1000125771", "3004858034", "3016405041", "3003559308", "1928237", "1920664", "2936921", "3008252121", "1000119305", "3009462521", "3004497289", "3045817901", "1000120916", "3006003617", "3001362763", "3010849408", "3016678045", "3009026057", "3012037425", "1000122089", "3009298127", "1317628", "3002807715", "1018470", "3000314405", "3003282815", "3002806902", "3005012805", "1000117501", "3002681132", "3005350457", "2939653", "1000121498", "3030860039", "3010487482", "3007589150", "3002807111", "1526711", "3002806863" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }