The Boston Lens II Alges(R) Bifocal Contact Lens

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Lens, contact (polymethylmethacrylate)

PMA Number

P850008 ↗

FDA Product Code

HPX

Device Class

U

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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See all devices from Unilens Corp., USA →

• What types of vision issues is this bifocal contact lens designed to address specifically?

  This lens is designed for patients with presbyopia or other conditions requiring both near and distance vision correction. The bifocal design provides dual focal points to assist with these needs, allowing users to see clearly at varying distances without switching lenses.

• Is this contact lens reusable, or is it intended for single-use only?

  The Boston Lens II Algés Bifocal Contact Lens is explicitly supplied as a single-use device. This ensures sterility and safety for clinical use, as it is intended for direct placement on the cornea without reuse.

• How is the sterility of this lens maintained for clinical use?

  The lens is packaged and maintained in a sterile state to meet clinical standards. Since it is single-use, sterility is preserved until the first application, eliminating the need for cleaning or reprocessing between patients.

• What materials is this contact lens made from, and why does that matter?

  The lens is made from polymethylmethacrylate (PMMA), a durable and biocompatible material commonly used in ophthalmic implants. PMMA provides clarity, stability, and resistance to wear, which are critical for long-term corneal contact and vision correction.

• How do I determine the correct size and power prescription for this lens?

  The available sizes and power prescriptions are detailed in the product documentation provided by Unilens Corp. Since this is a custom-fitted device, consultation with an eye care professional is required to select the appropriate prescription and ensure proper fit for the patient’s corneal curvature and vision needs.