FDA Sets Lower Limits Than ISO For Endotoxins In Fluids Used In Intraocular Lens Surgeries
This article was originally published in The Gray Sheet
Executive Summary
A new FDA guidance calls for adopting a limit of less than or equal to 0.2 endotoxin units/mL for release testing of ophthalmic viscosurgical devices used in IOL surgeries. The limit is less than what the International Organization for Standardization (ISO) calls for to control Toxic Anterior Segment Syndrome.