ISO-FDA regimen test for disinfection of contact lens

This test meets FDA 510(k) and ISO-14729 criteria for testing contact lens disinfectants according to a regimen of cleaning, rinsing, and soaking as recommended by the manufacturer. Lenses are challenged with Pseudomonas aeruginosa, Staphylococcus aureus, Serratia marcescens, Candida albicans, and Fusarium solani.

Study Outline

The FDA-ISO Contact Lens Disinfection, Regimen Test meets criteria for the FDA Pre-market Notification [510(k)] Guidance Document For Contact Lens Care Products and ISO-14729 Ophthalmic optics, Contact lens care products, Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses.

The disinfectants are tested according to a regimen of cleaning, rinsing, and soaking contacts as recommended by the manufacturer. Lenses are challenged with Pseudomonas aeruginosa, Staphylococcus aureus, Serratia marcescens, Candida albicans, and Fusarium solani. The organism suspensions are combined with organic soil consisting of heat killed yeast cells and heat inactivated serum to results in an initial concentration of 1 x 10⁷ - 1 x 10⁸ CFU/mL prior to inoculation.

Lenses are placed, concave surface up, in a sterile petri dish. Each lens is inoculated with 0.01 mL of test culture suspension on the under surface at the point of contact between the petri dish and the lens. An additional 0.01 mL aliquot is inoculated on the top surface of the lens. The inoculum is allowed to absorb into the lens for 5-10 minutes.

After absorption, the lenses are treated as described in the manufacturer's consumer instructions for lens disinfection including all steps of cleaning, rinsing, and soaking. If necessary, procedures are then performed in identical fashion for the predicate device unless otherwise stated in the manufacturer's consumer instructions for lens care.

A suitable volume of neutralizing medium is placed into a filtration apparatus and the entire content of each test lens case (lens and solution) is transferred to the medium. The solution is membrane filtered and the lens transferred to a bed of agar and cast using a pour plate method. The membrane is also plated onto agar medium.

Performance requirements state that less than or equal to 10 CFU are to be recovered from each lens and test filter combination for each test organism. Alternatively, the average number of surviving organisms recovered on the lens and the respective test filter should be shown to be substantially equivalent to results obtained for a predicate device. Organism counts may be considered to be substantially equivalent if the difference between the subject device and the predicate device is less than or equal to 0.5 log.

A neutralization study is completed for the organisms and sample types submitted to demonstrate the ability of the media to support organism growth.

Sample Requirements

A minimum of three lots of disinfectant are to be tested (1.5 liters each, minimum)

Please click here for a list of lens requirements.

Nelson Experts:

• Kimberlee Dickman 801-290-7858, 800-826-2088

Sample Requirements

A minimum of three lots of disinfectant are to be tested (1.5 liters each, minimum)

Please click here for a list of lens requirements.