Tinted Tetrafilcon A Contact Lenses

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

P840071 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

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• Are these contact lenses designed for overnight wear, or are they strictly for daily use only?

  These lenses are explicitly designed for daily wear only, as stated in the description. They are not intended for continuous overnight use, which would require a different classification (e.g., extended or continuous wear). Always follow the manufacturer’s guidelines for proper usage.

• How are these lenses packaged, and do they require sterilization before use?

  The lenses are supplied as single-use, non-sterile devices, with each lens individually packaged for patient convenience. Since they are intended for use in the eye without sterilization, proper hygiene practices (e.g., handwashing, clean storage) must be followed as per the manufacturer’s instructions to ensure safety.

• What regulatory pathway was followed for approval of these tinted contact lenses?

  These lenses were approved through the FDA Premarket Approval (PMA) process, with the PMA number P840071. This pathway is typically used for higher-risk medical devices, including certain contact lenses, to ensure safety and effectiveness before market authorization. The device is classified as a Class II under FDA regulations.

• Are these lenses reusable, or must they be discarded after one use?

  These lenses are single-use only and must be discarded after one use, as explicitly stated in the device description. Reuse is not recommended or supported by the manufacturer, as it could compromise hygiene and safety.

• What material are these tinted contact lenses made from, and does that affect their care or handling?

  These lenses are manufactured from Tetrafilcon A material, a silicone hydrogel polymer designed for soft contact lenses. While the material itself is durable for daily wear, it does not require sterilization before use (as they are non-sterile). Proper cleaning and disinfection solutions compatible with Tetrafilcon A must be used if the lenses are removed for overnight storage, though the manufacturer’s guidelines should be consulted for specific care instructions.