[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0307-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to incomplete seals in the pouch which provide the sterile barrier.
The recalled product
- 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' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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