FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

In September 2014, we reported about the FDA guidance draft on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Now, on 17 August, the FDA published the adopted version of that guidance document. The FDA developed this guideline related to the prevention respectively the weakening of future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized in the anterior segment of the eye following intraocular surgery. Former TASS outbreaks have been associated with endotoxin. This guidance provides recommendations for endotoxin limits, especially for devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments, because they can be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes. 

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. Endotoxin contamination of reusable manual ophthalmic surgical instruments is outside the scope of this guidance.

The devices covered are:

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

More details about the background and the recommendations can be found in the adopted Guidance for Industry and Food and Drug Administration Staff "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices".

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