United StatesCONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K surgical products are affected; affected items are identified by multiple REF and UDI codes (for example REF 8065000093, UDI‑DI 5414660389996) and total 28,323 units distributed worldwide. Alcon Research LLC (Fort Worth, TX) has issued an ongoing recall; the notice does not specify the hazard or what owners should do.
What's being recalled
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450…
Recalling firm: Alcon Research LLC, Fort Worth, TX, United States.
How to identify it
UDI-DI/REF: 5414660389996/C26992-01; 5414660396666/C23069-05; 5414660396697/C23125-04; 5414660400332/C17655-06; 5414660400356/C17731-06; 5414660401254/C27454-02; 5414660401285/C27450-02; 5414660401292/C27449-02; 5414660405221/C27453-03; 5414660409380/C27818-04; 5414660409700/C27864-01 5414660410225/C27876-01; 5414660413356/C28044-05; 5414660413691/C19139-07; 5414660417668/C25243-02; 5414660418221/C27440-02; 5414660418238/C27441-03, 5414660418245/C27442-02; 5414660418252/C27443-02; 5414660418269/C27444-02; 5414660418276/C27445-02; 5414660420620/C28328-02; 5414660421061/C21524-03; 5414660421078/C18093-04; 5414660421993/C27789-08; 5414660423874/C27007-03; 5414660427759/C19940-07; 5414660429029/C26049-02; 5414660434382/C29260-01; 5414660434412/C26740-08; 5414660434429/C26739-09; 5414660434443/C21175-07; 5414660434450/C28294-04; 5414660434542/C24151-06; 5414660434559/C29080-03; 5414660434580/C28885-03; 5414660434597/C28884-03; 5414660434603/C28883-05; 5414660434658/C27558-03; 5414660434665/C20382-07; 5414660434733/C29015-03; 5414660434870/C24900-04; 5414660434931/C27086-04; 5414660434948/C27091-05; 5414660435150/C28673-03; 5414660435167/C28738-03; 5414660435228/C29261-01/ 5414660435617/C26731-04; 5414660435648/C22375-13; 5414660435662/C26854-09; 5414660436171/C29271-01; 5414660436263/C29272-01; 5414660436539/C28996-04; 5414660436591/C25163-05; 5414660436607/C22118-04; 5414660436744/C23137-11; 5414660436768/C25162-05; 5414660436775/C26763-04; 5414660444206/C28786-01; 5414660446538/C28835-01; 5414660447726/C28795-02; 5414660448983/C28005-03; 5414660448990/C28024-04; 5414660450610/C28908-01; 5414660450948/C27548-02; 5414660450955/C27549-02; 5414660450962/C27550-02; 5414660453888/C28686-03; 5414660454977/C24333-05; 5414660456223/C28950-01; 5414660457237/C19081-10, C19081-10-01; 5414660457985/C26224-06; 5414660458975/C21162-07; 5414660459019/C24998-04; 5414660459439/C25768-03; 5414660461555/C19947-10; 5414660462576/C22297-04; 5414660462880/C28595-02…
The hazard
XXX
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)