{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216416", "product_res_number": "Z-0581-2026", "event_date_initiated": "2025-09-15", "event_date_posted": "2025-11-21", "recall_status": "Open, Classified", "res_event_number": "97728", "product_code": "HQB", "k_numbers": [ "K110951" ], "product_description": "CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: \n25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/\t8065000093;\n25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/\t8065000095;\n27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/\t8065000096;\n23GA BEVEL ULTRAVIT 10,000 CPM/\t8065752413;\n25+ BEVEL ULTRAVIT 10,000 CPM/\t8065752415;\n27+ BEVEL ULTRAVIT 10,000 CPM/\t8065752417;\nTOTAL PLUS,23G,10K VALVE STD/\t8065752435;\nTOTAL PLUS,23GA,10K VALVE WD/\t8065752436;\nTOTAL PLUS,25+,10K VALVE STD/\t8065752437;\nTOTAL PLUS,25+,10K VALVE WD/\t8065752438;\nTOTAL PLUS,27+,10K VALVE STD/\t8065752439;\n23G CMB PAK 10K CPM,V,STD 0.9/\t8065752448;\n23G CMB PAK 10K CPM,V,WA 0.9/\t8065752449;\n25+ CMB PAK 10K CPM,V,STD 0.9/\t8065752450;\n25+ CMB PAK 10K CPM,V,WA 0.9/\t8065752451;\n27+ CMB PAK 10K CPM,V,STD 0.9/\t8065752452;\n25+TTLPL VPK 20000CPM BEV VAL/\t8065753106;\n27+TTLPL VPK 20000CPM BEV VL/\t8065753109;\nHYPERVIT 25+BEV 20000 CPM/\t8065830026;\nHYPERVIT 27+BEV 20000 CPM/\t8065830027;\n25+ TTL PLUS VPAK 20000CPM BWV/\t8065830077;\n25G VIT 25G OPTICARE EYE HLTH CTR/\t10924-15;\nVITRECTOMY 25G NORTHSIDE HOSP/\t11220-25;\nVITRECTOMY 25G NORTHSIDE HOSP/\t11220-27;\n23G CONSTELLATION NORTHERN MICH SPPLY AL/\t12568-09;\nAUS-25GA VIT RET BRISBANE WATERS/\t12641-13;\nAUS-25GA VIT RET BRISBANE WATERS/\t12641-14;\nAUS-23GA 10K COMBINED VR PAK NEW CHILDRE/\t12852-16;\n23G VIT CONSTELLATION LOMA LINDA COMM HO/\t13501-08;\n25+G 20K VIT CONSTELLATION LOMA LINDA CO/\t13502-10;\n23G VIT CONSTELLATION VALVED BAYSTATE ME/\t13591-13;\n25G CONSTELLATION VALVED BAYSTATE MEDICA/\t13592-15;\nVITRECTOMY 25G V A HOSPITAL/\t14129-10;\nJ-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/\t14283-12;\nCDN-CVS VIT 25G VE 10K TIMMINS DH/\t14501-09;\nCDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/\t14512-09;\nCDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/\t14512-10;\nCDN-CVS VIT 23G 10K WA SASKATOON HR/\t14532-06;\nCDN-CVS VIT 23G 10K WA SASKATOON HR/\t14532-07;\nCDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/\t14540-08;\nCDN-CVS COMBO 23G VE 10K HD KINGSTON/\t14541-16;\nCDN-CVS VIT 25G+ 20K BV JEWISH GH/\t14597-07;\nCDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/\t14603-15;\nCDN-CVS COMBO 25G VE 10K TIMMINS DH/\t14669-10;\nCDN-CVS COMBO 25G VE 10K TIMMINS DH/\t14669-11;\nCDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/\t14671-09;\nCDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/\t14672-11;\nCDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/\t14873-06;\nCDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/\t14873-07;\nCDN-VIT 23G VE 10K ST MICHAEL'S HOSP/\t14955-08;\nCDN-VIT 23G VE 10K ST MICHAELS HOSP/\t14955-09;\nCDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/\t14956-07;\nCDN-CVS 25G+ VIT VE 10K ST MICHAELS/\t14956-08;\nCDN-CVS VIT 25G+ 10K WESTERN MH/\t15006-06;\nCDN-CVS VIT 25G+ 20K WA WESTERN MH/\t15006-07;\nCDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/\t15108-09;\nCDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/\t15167-08;\n25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/\t15223-13;\nCDN-VIT 23G 10K GRM741746 CUO-HSS/\t15294-14;\nCDN-COMBO 23G 10K GRM741759 CUO-HSS/\t15295-12;\nCDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/\t15318-05;\nCDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/\t15318-06;\nCDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/\t15318-07;\nCDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/\t15324-07;\nCDN-COMBO 25G 20K GRM743287 CUO-HSS/\t15421-13;\nCDN-COMBO 25G 20K GRM743287 CUO-HSS/\t15421-14;\nCDN-UHN 23G COMBO VE 10K TORONTO WESTERN/\t15455-08;\nCDN-UHN 23G COMBO VE 10K TORONTO WESTERN/\t15455-09;\nCDN-UHN 23G COMBO VE 10K TORONTO WESTERN/\t15455-10;\nCDN-UHN 23G VIT VE 10K TORONTO WESTERN/\t15456-04;\nCDN-UHN 23G VIT VE 10K TORONTO WESTERN/\t15456-05;\nCDN-UHN 23G VIT VE 10K TORONTO WESTERN/\t15456-06;\nCDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/\t15464-05;\nCDN-CVS 23G VIT VE 10K SUNNYBROOK GH/\t15465-05;\n23G VIT PACK CALLAHAN EYE FOUNDATION HOS/\t15491-05;\n23G VIT PACK CALLAHAN EYE FOUNDATION HOS/\t15491-06;\n27G VIT PACK CALLAHAN EYE FOUNDATION HOS/\t15492-02;\n27G VIT PACK CALLAHAN EYE FOUNDATION HOS/\t15492-03;\n25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/\t15493-05;\n25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/\t15493-06;\nCDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/\t15525-04;\nCDN-CVS COMBO 23G VE 10K KENSINGTON EI/\t15552-05;\nCDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/\t1", "code_info": "UDI-DI/REF: 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15318-05, 15318-06, 15318-07, 19098-02, 17585-03, 17585-04, 17585-05, 19531-01, 19531-02, 15852-05, 18150-04, 18150-05, 18723-11, 18723-12, 18723-10, 15455-08, 15455-09, 15455-10, 15456-04, 15456-05, 15456-06, 15294-14, 14955-09, 14955-08, 17141-06, 17141-07, 20147-01, Q39446B, 19037-03, AS19037-03, Q39448B, 19037-05, AS19037-05, 17000-03, AS17000-03, 15576-04, AS15576-04, 18202-01, AS18202-01, 16677-03, AS16677-03, 16481-04, AS16481-04, 17263-02, AS17263-02, 15642-08, AS15642-08, 16334-03, AS16334-03, 14283-12, AS14283-12, 18131-03, AS18131-03, 19009-01, AS19009-01, 8224-65, AS8224-65, 18703-01, AS18703-01, 17262-02, AS17262-02, 17770-04, AS17770-04, 16335-03, AS16335-03, 18130-03, AS18130-03, 19010-01, AS19010-01, 15877-07, AS15877-07, 18702-01, AS18702-01, Q39315A, 15876-07, AS15876-07, 20235-02, AS20235-02, 20236-02, AS20236-02, 19657-01, AS19657-01, 19178-02, AS19178-02, 19178-04, AS19178-04, 19656-01, AS19656-01, 19200-01, 19200-02, AS19200-01, AS19200-02, 19150-02, 19150-03, AS19150-02, AS19150-03, 17604-08, AS17604-08, 20234-01, AS20234-01, 19211-01, 19211-02, 19211-03, AS19211-01, AS19211-02, AS19211-03, 19212-02, 19212-03, AS19212-02, AS19212-03, 18422-02, 18421-03, 11220-25, 11220-27, 14129-10, 18186-10, 18186-14;\nH5301ALCON1CPAK11/AS12852-16;\nH5301ALCON1CPAK12/18269-02;\nH5301ALCON1CPAK13/AS18269-02;\nH5301ALCON1CPAK14/12641-13;\nH5301ALCON1CPAK15/12641-14;\nH5301ALCON1CPAK16/AS12641-13;\nH5301ALCON1CPAK17/AS12641-14;\nH5301ALCON1CPAK18/18271-02;\nH5301ALCON1CPAK19/AS18271-02;\nH5301ALCON1CPAK20/17607-05;\nH5301ALCON1CPAK21/AS17607-05;\nH5301ALCON1CPAK22/20122-01;\nH5301ALCON1CPAK23/AS20122-01;\nH5301ALCON1CPAK24/17609-04;\nH5301ALCON1CPAK25/17609-05;\nH5301ALCON1CPAK26/17609-06;\nH5301ALCON1CPAK27/AS17609-04;\nH5301ALCON1CPAK28/AS17609-05;\nH5301ALCON1CPAK29/AS17609-06;\nH5301ALCON1CPAK30/18684-05;\nH5301ALCON1CPAK31/AS18684-05;\nH5301ALCON1CPAK32/18454-07;\nH5301ALCON1CPAK33/AS18454-07;\nH5301ALCON1CPAK34/18453-05;\nH5301ALCON1CPAK35/18453-06;\nH5301ALCON1CPAK36/AS18453-05;\nH5301ALCON1CPAK37/17368-04;\nH5301ALCON1CPAK38/AS17368-04;\nH5301ALCON1CPAK39/17369-04;\nH5301ALCON1CPAK40/AS17369-04;\nH5301ALCON1CPAK41/19747-01;\nH5301ALCON1CPAK42/AS19747-01;\nH5301ALCON1CPAK43/16873-11;\nH5301ALCON1CPAK44/AS16873-11;\nH5301ALCON1CPAK45/18833-04;\nH5301ALCON1CPAK46/AS18833-04;\nH5301ALCON1CPAK47/16873-09;\nH5301ALCON1CPAK48/AS16873-09;\nH5301ALCON1CPAK49/18826-03;\nH5301ALCON1CPAK50/AS18826-03;\nH5301ALCON1CPAK51/16871-10;\nH5301ALCON1CPAK52/16871-11;\nH5301ALCON1CPAK53/AS16871-10;\nH5301ALCON1CPAK54/AS16871-11;\nCustomer evaluation sample - UDI N/A/QNS29389-01, QNS29388-01, QNS29239-01, QNS29385-01, QNS29407-01, QNS29406-01, QNS29365-01, QNS29364-01, QNS29374-01, QNS29373-01, QNS29337-01, QNS29338-01, QNS29339-01, QNS29333-01, QNS29353-01, QNS29352-01, QNS29348-01", "firm_fei_number": "1610287", "recalling_firm": "Alcon Research LLC", "address_1": "6201 South Fwy", "city": "Fort Worth", "state": "TX", "postal_code": "76134-2099", "additional_info_contact": "Kristen Kellerhals\n817-615-5472", "reason_for_recall": "XXX", "root_cause_description": "Component change control", "action": "On 9/15/2025, correction notices were mailed to customers who were informed of the following:\n\nSuitable alternative probes are available. Please stop using affected UNITY ULTRAVIT 10K 25+ probes and contact your Alcon Sales Representative to arrange for replacement of your existing stock.\n\nNo direct substitution is available for the 23 gauge size of UNITY ULTRAVIT 10K probes. To prevent a probe shortage and the resulting risk of cancelling emergency and time-sensitive posterior segment surgeries, Firm will continue to ship probes until non-affected probe inventory is available.\n\nFirm advises customers to take the following precautions with affected UNITY ULTRAVIT 10K 23G probes until non-affected probe inventory is available:\n1) Strictly adhere to the Instructions for Use (IFU) regarding limitations, including maximum use time and single use only.\n2) Reduce the actuation rate to no more than 5000 actuations per minute.\n3) Adjust other related console settings as needed to accommodate the reduced cutting/actuation rate.\n4) If a reduction of cutting capability or failure to actuate is observed during the surgical procedure, stop immediately. Take all necessary surgical precautions to remove the probe and replace it with an unused probe.\n\nPost this notification letter near where affected products are stored to make facility personnel aware of this Medical Device Correction and associated firm corrective action.\n\nForward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.\n\nComplete and return the response form via email to Market.Actions@Alcon.com\n\nFirm will notify customers regarding replacement inventory as soon as adequate inventory of new, non-affected probes is available.\n\nAdverse events can be reported to firm at: https://notifeye.alcon.com or by phone (1-800-757-9780, Option 5).\n\nQuestions can be directed to firm customer servic", "product_quantity": "28323", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND, HI, ME, IA, MS, NV, OK, WV, VT and the countries of GB, CA, IE, CH, JP, AT, CZ, GR, HU, PL, TR, ZA, MU, ZM, SA, IL, KW, BD, UZ, LB, LV, AZ, MN, IR, MK, VN, MT, AE, ID, CY, MD, RS, QA, LK, DZ, EG, TN, BG, OM, HR, KH, IT, NL, LU, BE, JO, BH, ES, PT, FI, SE, DK, IS, RO, RU, UA, DE, FR, MQ, AU, NZ, HK, MO, SG, PH, PF, GF, GP, NC, RE, KR, IN, TH, TW, MY, BN, CN, IQ, SI, MA, CL, EC, MX, PE, PK, AR, BR, CO, UY, JM, BS, DO, TT, GT, CR, BB, AW, SK, KZ, BY, AM, SV, SR, KG, UG, PA, NI, PY, HN.", "openfda": { "k_number": [ "K844198", "K113857", "K110951", "K780345", "K772213", "K882679", "K843966", "K922735", "K191846", "K760444", "K954306", "K122997", "K954308", "K923531", "K844209", "K110228", "K964380", "K882441", "K182646", "K954307", "K881926", "K220263", "K924090", "K844197", "K132614", "K111493", "K844356", "K122905", "K801877", "K860011" ], "registration_number": [ "2028159", "3045817901", "3002991496", "1313525", "3010208880", "9615745", "1932402", "1018470", "3012037425", "3002807715", "2246552", "3015456951", "1650907", "9611516", "3010220595", "3007589150", "3004497289", "9681121", "2523835", "3013002167", "3002808022", "8030392", "2529392", "3004467263", "3010487482", "3016678045", "1928237", "2936921" ], "fei_number": [ "3045817901", "3002991496", "3010208880", "3002807944", "1000125771", "1018470", "3012037425", "3002807715", "2246552", "3000314405", "1317628", "3015456951", "3010220595", "3007589150", "3002806863", "3002681132", "3004497289", "2523835", "3013002167", "1000119053", "1000121498", "3002808022", "3004467263", "3010487482", "3016678045", "1928237", "2936921" ], "device_name": "Photocoagulator And Accessories", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4690", "device_class": "2" } } ] }