DeviceClearance

Recall Z-0304-2026— Alcon Research LLC

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2025-08-05. It names 3 FDA 510(k) clearances: K242184, K233876, K141065. Product: Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A. Reason: Due to incomplete seals in the pouch which provide the sterile barrier..

Recalling firm
Alcon Research LLC
Classification
Class II
Status
Ongoing
Initiated
2025-08-05
Firm location
Fort Worth, TX, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

Reason for recall

Due to incomplete seals in the pouch which provide the sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.