[pending] Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0304-2026.
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' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
- Manufacturer
- Alcon Research LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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