Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.
Description du dispositif
Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. || The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.
Description du dispositif
Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. || The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.