CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065

FDA device recall Z-0581-2026 · posted 2025-11-21 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

XXX

Action taken

On 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 customers to take the following precautions with affected UNITY ULTRAVIT 10K 23G probes until non-affected probe inventory is available: 1) Strictly adhere to the Instructions for Use (IFU) regarding limitations, including maximum use time and single use only. 2) Reduce the actuation rate to no more than 5000 actuations per minute. 3) Adjust other related console settings as needed to accommodate the reduced cutting/actuation rate. 4) 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. Post this notification letter near where affected products are stored to make facility personnel aware of this Medical Device Correction and associated firm corrective action. Forward 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. Complete and return the response form via email to Market.Actions@Alcon.com Firm will notify customers regarding replacement inventory as soon as adequate inventory of new, non-affected probes is available. Adverse events can be reported to firm at: https://notifeye.alcon.com or by phone (1-800-757-9780, Option 5). Questions can be directed to firm customer servic

Root cause

Component change control

Status

Open, Classified

Product code

HQB

Quantity affected

28323

Distribution

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

Date initiated

2025-09-15

Date posted

2025-11-21

Location

Fort Worth, TX

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