Device Recall Viscocel and Viscocel Plus

  • Model / Serial
    All lots manufactured September 01, 2011 to September 19, 2013.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Egypt, Mexico, and Canada.
  • Product Description
    Viscocel and Viscocel Plus. || These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    C.L.R. Medicals International, Inc., 748 E Bonita Ave Ste 210, Pomona CA 91767-1922
  • Manufacturer Parent Company (2017)
  • Source
    USFDA