ReNu is a medical device, regulated by the FDA. The trade device name for the product in question is Bausch & Lomb ReNu with MoistureLoc multi-Purpose Solution, Regulation number 21 CFR 886.5928, Regulatory Name, soft (hydrophilic) contact Lens Care Product, Regulatory Class II, Product code LPN. Bausch & Lomb designed, developed, tested, manufactured, packaged, labeled, marketed, advertised, distributed and/or sold a contact lens care product known as Baush & Lomb ReNu with MoistureLoc Multi-Purpose Solution.
Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution was indicated for use in daily cleaning, removal of protein deposits, rinsing, chemical (not hot) disinfection and storage of soft (hydrophilic) contact lenses (including silicon hydrogel lenses). Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution is defined under FDA regulations as an over the counter device which did not require a prescription.
Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution is a class II medical device approved by the Food and Drug administration using the section 510(k) substantial equivalency procedure. As such, Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution was not approved using the full NDA process. The predicate devices upon which the substantial equivalency was based were Alcon OPTI-FREE Express Multi-Purpose Disinfecting Solution and Ciba Vision AQuify Multi-Purpose Solution.
Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution was designed to be a sterile isotonic solution containing boric acid, sodium chloride, sodiumphosphate, Hydranate® (hydroxyalkylphosphonate), poloxamer 407, polyquaternium-10, poloxamine 1107, purified water and preserved with alexidine dihydrochloride (0.00045%).
Bausch & Lomb claimed, in advertisements to the general public, that this product is "No Rub" and "Cleans, Disinfects, Rinses, Stores, [and] Removes Protein Daily" providing 16 hours of comfort and implying that the comfort after 16 hours of contact lens use was substantially superior to competing contact lens solutions. Defendant Bausch and Lomb also claimed in public advertisements that ReNu with MoistureLoc "kills germs best to help keep your vision crisp and your eyes healthy."
