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Aug 29 2018

Alcon Withdraws CyPass Stents

posted by: J. James Thimons, OD, FAAO

The release of the 5 year CyPass data shows a small but statistically significant difference in endothelial cell count between CyPass with CEX vs CEX alone. This was announced this morning and has initiated the recall that is referenced in the following article on the Alcon website: Alcon CyPass Recall.

It is unclear if Alcon will resubmit the device after consultation with the FDA. In the interim, I have adopted a protocol of obtaining a baseline Endo Cell count for all patients under co-management and follow up ECC’s initially on a 6 month cycle until further information is released.