medical Class I Updated 2018-10-31

Alcon Research, LTD. recalls CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF

Recalled Product

CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.


Hazard / Issue

Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 00380657540075, 10380657540072, 20380657540079 All lot/serial numbers
View official government recall

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