What is Ophthalmic BSS?
Ophthalmic BSS are sterile, isotonic, irrigating solutions used during surgical procedures on the eye. Ophthalmic BSS for use during ocular surgery were developed in the 1960s to provide a temporary replacement for the fluid in the eye. This enables more complex intraocular surgery techniques to be conducted that require the replacement of larger amounts of intraocular fluid. Some of the ophthalmic BSS marketed today are designed for use in surgical procedures of limited duration, while others are appropriate for use in procedures of any expected duration. Why is FDA taking this action? FDA is taking this action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and appropriately labeled. Unapproved ophthalmic balanced salt solutions have been associated with adverse events, some of them leading to permanent loss of vision, because of contamination of the product or other produc
