A guidance has been posted titled, “Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff.”
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.
To view the Guidance, please see:
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM393376. pdf.