Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation su
Pending LLM rewrite. Source: FDA_DEVICE Z-0304-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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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