# K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 15, 2007 after 100 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943177 (1994). 8 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000795: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 1.
- K001960: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 1.
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Incorporated (2006) Summary page 1.
- K011945: Rigid Gas Permeable Contact Lens Solution, Polymer Technology Corp. (2001) Summary page 1.

## Most influential descendants
- K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (2016), 20 descendants of its own
- K161461: BostonSight PD Prosthetic Device (2016), 19 descendants of its own
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), 14 descendants of its own
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (2018), 9 descendants of its own
- K212631: Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (2022), 7 descendants of its own

## Recalls of this device
- Jul 3, 2018 · Class III · Z-2982-2018: Vials labeled for the prescriptions contained incorrect lenses
- Jul 3, 2018 · Class III · Z-2981-2018: Vials labeled for the prescriptions contained incorrect lenses

## Indications for use
The BOSTON X02 Gas Permeable Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lens is also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Source page: https://510kreport.com/device/K071266
Methodology: https://510kreport.com/methodology