(100 days)
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyocia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.
BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.
BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.
BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).
Here's a breakdown of the acceptance criteria and the study details for the Bausch & Lomb BOSTON RGP Lenses wet-shipped in BOSTON SIMPLUS® Multi-Action Solution:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability of physical and optical properties | Testing demonstrated stability as to physical and optical properties in accordance with ISO 11987:1997 Ophthalmic Optics - Determination of Shelf-life and WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a 30-day shelf-life. |
| Bioburden levels | Bioburden levels were below the required minimum cfu values ( |
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.