Aquaflex (Tetrafilcon A) Contact Lenses

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

Full name

Aquaflex[Tetrafilcon a] Contact Lenses/Shelf Life

Generic Name

Lenses, soft contact, daily wear

PMA Number

P880101 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S005 (Normal 180 Day Track)

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• Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens

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• Unilens 38 Soft Aspheric Contact Lens

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• Seesoft (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens

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• Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, Ll-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,

  Class II

  FDA 510(k) K110452 Active Cleared 20 Apr 2011

See all devices from Unilens Corp., USA →

• Are these contact lenses designed for daily wear only, or can they be worn for extended periods like overnight?

  The Aquaflex (Tetrafilcon A) Contact Lenses are explicitly designed for daily wear only, meaning they are intended for daytime use and should not be worn overnight or for extended periods beyond the prescribed duration. The silicone hydrogel material (tetrafilcon A) enhances oxygen permeability and moisture retention, but this does not alter the manufacturer’s recommendation for daily removal.

• How are these lenses supplied, and do they come in single-use or reusable options?

  The Aquaflex (Tetrafilcon A) lenses are supplied in both single-use and multi-use formats, depending on the specific prescription. Single-use lenses are intended for one-time wear and disposal, while multi-use lenses are designed for repeated wear over several days with proper cleaning and care. The packaging clearly indicates the intended use (single-use or multi-use) to guide proper handling.

• What should I know about the sterility and storage of these contact lenses?

  The lenses are sterile as packaged, with sterility maintained through manufacturer-specified packaging and handling procedures. They should be stored according to the instructions provided on the packaging, typically in a cool, dry place away from direct sunlight. Once opened, single-use lenses must be used immediately, while multi-use lenses require adherence to a cleaning and storage regimen to preserve sterility and performance.

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

  The Aquaflex (Tetrafilcon A) lenses were authorized under the FDA Premarket Approval (PMA) process, specifically through PMA number P880101. This pathway is used for Class II devices like soft contact lenses to ensure their safety and effectiveness for ophthalmic use. The approval includes compliance with FDA requirements for daily-wear soft contact lenses.