Tristel OPH

Tristel OPH is a high-level disinfectant foam for reprocessing ophthalmic devices that contact mucous membranes, such as diagnostic lenses, tonometer prisms, pachymeters, and retinal imaging probes. It consists of two solutions (Activator and Base) that mix when dispensed to generate chlorine dioxide at ~320 ppm, achieving disinfection in 2 minutes at room temperature when used with single-use Tristel OPH Wipes.

Tristel OPH is identical to the predicate Tristel Duo ULT in active chemistry (chlorine dioxide), concentration (~320 ppm), contact time (2 minutes), packaging (dual-compartment dispenser bottle), wipe characteristics (dry, non-woven, low-linting), and shelf life (2 years unopened, 6 months opened). The primary difference is that Tristel OPH requires 2 foam doses per use for smaller ophthalmic devices versus 4 doses for the larger ultrasound probes treated by the predicate.

AOAC 955.15, 964.02, 955.14, 955.17, 966.04; ASTM E1053; Ascenzi et al., 1987; ISO 10993-5 and ISO 10993-10 for biocompatibility; OSHA and California Division of Occupational Safety and Health standards for inhalation exposure limits.

Tristel OPH uses identical chlorine-dioxide chemistry, concentration, contact time, packaging design, and single-use wipe system as the predicate Tristel Duo ULT. Non-clinical testing demonstrates equivalent or superior antimicrobial efficacy (bactericidal, fungicidal, virucidal, mycobactericidal, and sporicidal), biocompatibility, residue safety, and occupational inhalation safety. The only intended-use difference is the category of semi-critical devices (ophthalmic vs. ultrasound), which does not alter the fundamental disinfection mechanism or safety profile, and the smaller foam dose requirement reflects appropriate adaptation to device size rather than a change in performance.