Issue Date: August 17, 2015
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Ophthalmic
Status: Final
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices
This guidance document was developed to notify manufacturers of the recommended endotoxin limit for the release of intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories in an effort to mitigate future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized to the anterior segment of the eye following intraocular surgery. It has been associated with significant decreases in vision and may require additional surgical procedures, including corneal transplants and glaucoma surgery, to resolve some of its sequelae.
Download the Guidance Document
