Urgent Field Safety Notice For Healon Endocoat Pro, Healon Duet Pro II By Amo Uppsala Ab
Summary AMO Uppsala AB has issued an urgent field safety notice for two eye surgery products: Healon EndoCoat PRO and Healon Duet PRO II. These products are distributed in Germany and the European Union and are classified as Class I devices, indicating a serious safety concern. The notice affects patients and healthcare facilities in those regions who use or have these products.
- Recalling firm
- AMO Uppsala AB
- Product
- Healon EndoCoat PRO, Healon Duet PRO II
- Reason
- Urgent Field Safety Notice for Healon EndoCoat PRO, Healon Duet PRO II by AMO Uppsala AB
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-08-24
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/0c040201-d5c2-495c-a001-9af57c143998