ClearanceBrief
Recall Z-0581-2026 ยท HQB Photocoagulator And Accessories

Alcon Research LLC

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/ 806575243

DateNov 21, 2025 (initiated Sep 15, 2025)
StatusOpen, Classified
ReasonXXX
Root causeComponent change control
ActionOn 9/15/2025, correction notices were mailed to customers who were informed of the following: Suitable 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. No 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. Firm advises c
Quantity28323
DistributionWorldwide - 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
Alcon Research, Ltd., Oct 17, 2011