Device Recall Zyoptix

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer