FDA: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

A new FDA guidance document has been 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 has required additional surgical procedures, including corneal transplants and glaucoma surgery, to resolve some of its sequelae.

National outbreaks of TASS have been associated with endotoxin. Devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories, can potentially be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions [510(k)s] for different categories of intraocular devices to aid in the prevention of future outbreaks of TASS.

For details of the draft, see FDA

Posted by Tim Sandle