Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

Related to several outbreaks of Toxic Anterior Segment Syndrome (TASS) in the past, the U.S. Food and Drug Administration and other government and professional organizations started a collaboration to monitor rare eye condition associated with cataract surgery to help industry develop tools for improving safety of eye surgery medical devices. (see FDA News Release December 2011).

Now the FDA published a Draft Guidance for Industry and for Food and Drug Administration Staff on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Because some of the national outbreaks of TASS have been associated with endotoxin, 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. The 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.

The recommendations made in this guidance are applicable to devices used within the eye, either as permanent implants or as single-use devices used in intraocular surgery. These include:

A. Intraocular Fluids (21 CFR 886.4275, Class III), including

• Intraocular fluid (LWL)
• Viscoelastic surgical aid (LZP)

B. Anterior Segment Solid Devices
1.Intraocular lenses (21 CFR 886.3600, Class III), including

• Intraocular lenses (HQL)
• Multifocal intraocular lenses (MFK)
• Phakic intraocular lenses (MTA)
• Toric intraocular lenses (MJP)
• Accommodative intraocular lenses (NAA)
• Implantable miniature telescope (NCJ)
• Iris reconstruction lenses (NIZ)

2. Capsular tension ring devices (Class III), including

• Endocapsular rings (MRJ)

3. Glaucoma devices

• Aqueous shunts (21 CFR 886.3920, Class II), including
   - Eye valve implant (KYF)
• Other glaucoma devices (Class III)
   - Intraocular pressure lowering implants (OGO)

4. Phacofragmentation systems (21 CFR 886.4670, Class II), specifically the accessories of irrigation/aspiration sleeves and tubing (HQC)

• Posterior Segment Solid Devices (Class III)
• Retinal prostheses (NBF)