Tri Pol 43 Contact Lens

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17951 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

• What is the Tri Pol 43 Contact Lens primarily used for and how does it differ from other contact lenses?

  The Tri Pol 43 Contact Lens is designed specifically for daily wear, meaning it is intended to be worn throughout the day and removed at night. Unlike some contact lenses that may be worn overnight or for extended periods, this lens is not approved for continuous wear. It falls under the category of soft contact lenses, which are typically made from flexible, water-absorbing materials to ensure comfort and proper oxygen transmission to the eye.

• Is the Tri Pol 43 Contact Lens single-use or reusable, and how should it be handled to maintain sterility?

  The Tri Pol 43 Contact Lens is supplied as a sterile, single-use product. This means each lens is intended for one-time use only and should not be reused. To maintain sterility, the lens should be handled using sterile techniques, such as wearing gloves, and opened only in a clean environment. Since it is single-use, it should not be stored for future use.

• What regulatory pathway does the Tri Pol 43 Contact Lens follow, and what does this mean for its use?

  The Tri Pol 43 Contact Lens follows the FDA Premarket Approval (PMA) pathway, indicated by the PMA number (N17951) and the decision code (APPR). This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use. Clinicians and patients can rely on this approval as evidence that the lens meets stringent regulatory standards before being marketed.

• Are there multiple sizes or models available for the Tri Pol 43 Contact Lens, and how can I determine the correct fit?

  Yes, the Tri Pol 43 Contact Lens is available in various sizes and models, as indicated by the multiple registration numbers listed in the device data. The correct size or model for a patient should be determined by an eye care professional, such as an optometrist or ophthalmologist, based on an eye examination and fitting process. This ensures the lens provides optimal vision correction, comfort, and eye health.

• Where was the Tri Pol 43 Contact Lens originally submitted for approval, and what does this mean for its manufacturing standards?

  The Tri Pol 43 Contact Lens was originally submitted for approval to the FDA in Kensington, Maryland, as indicated by the city and address provided. The fact that it received FDA PMA approval suggests that the manufacturing processes, materials, and design adhere to strict regulatory standards set by the FDA. This approval process ensures that the lens is produced under controlled conditions to maintain quality, safety, and efficacy.