SOF-FORM II Contact Lenses

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

Full name

(Polymacon) Sof-Form II Contact Lenses

Trade Name

(Polymacon) Contact Lenses

Generic Name

Lenses, soft contact, daily wear

PMA Number

P820005 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

• Paraperm O2 Clear & Blue Lens

  Class II

  FDA PMA P820062 Active Approved 16 Mar 1984

• SOF-FORM Allvue Multifocal (Polymacon) Contact Lens

  Class II

  FDA PMA P840006 Active Approved 17 May 1985

• Are these contact lenses intended for overnight wear or only daily use as part of a daily wear regimen?

  The SOF-FORM II Contact Lenses are explicitly designed for daily wear only, meaning they are intended to be worn during the day for vision correction and removed before sleep. The description specifies they are not intended for extended or overnight wear, so they should not be worn continuously beyond the recommended daily schedule.

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

  The SOF-FORM II lenses are supplied as single-use, non-sterile devices. They are intended to be professionally fitted and dispensed by eye care practitioners, who must follow proper hygiene protocols (e.g., cleaning, disinfection, or sterilization of the packaging or tools) before handling or inserting them into a patient’s eye. The lenses themselves are not pre-sterilized.

• What should I consider when storing these lenses to maintain their integrity?

  Since these lenses are non-sterile and single-use, storage must adhere to manufacturer instructions to preserve their condition. They should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Avoid storing them in humid or contaminated areas, as this could compromise their material integrity or introduce microbial contamination before use.

• What regulatory pathway was followed for approval of these lenses, and what class do they fall under?

  The SOF-FORM II Contact Lenses underwent FDA Premarket Approval (PMA) under the classification of Class II medical devices. This route was required due to their role in correcting refractive errors and resting directly on the cornea, which carries potential risks. The PMA process ensures their safety and effectiveness before market authorization.

• Are there multiple sizes or dioptric powers available, and how do I determine the correct fit for a patient?

  Yes, the SOF-FORM II lenses come in multiple sizes and dioptric powers, as indicated by the listed registration numbers (e.g., 3015533540, 3012546757). The correct fit depends on the patient’s prescription, corneal curvature, and eye measurements, which must be assessed by an eye care practitioner during a professional fitting. The practitioner selects the appropriate lens based on these parameters to ensure comfort and optimal vision correction.