AL-47 Soft Contact Lens

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

Generic Name

Lenses, soft contact, daily wear

PMA Number

P820078 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APRL

• Alden Hp 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden Hp 54 Multifocal &Hp 54 Toric Multifocal Contact Lenses

  Class II

  FDA 510(k) K091327 Active Cleared 25 Jun 2010

• Al-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-Cut From Lens Blank)

  Class II

  FDA 510(k) K973967 Active Cleared 8 Dec 1997

• Alden Hp (Hioxifilcon B) Sphere & Toric Soft Contact Lenses

  Class II

  FDA 510(k) K042242 Active Cleared 15 Sep 2004

• Novakone Spherical and Toric Lenses

  Class II

  FDA 510(k) K102557 Active Cleared 26 Apr 2011

• Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing)

  Class II

  FDA 510(k) K980554 Active Cleared 7 Apr 1998

• Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and Non-Sighted Eyes)

  Class II

  FDA 510(k) K983053 Active Cleared 21 Oct 1998

See all devices from Alden Optical Labs., Inc. →

• What types of vision corrections can the AL-47 Soft Contact Lens address, and how does it differ between spherical and toric variants?

  The AL-47 Soft Contact Lens is designed to correct both spherical refractive errors (nearsightedness or farsightedness) and astigmatism. The spherical variant addresses standard refractive errors, while the toric variant is specifically engineered to correct astigmatism by providing a unique curvature that matches the irregular corneal shape. Both variants are made from polymacon, a hydrophilic material that ensures comfort and clarity during daily wear.

• Is the AL-47 Soft Contact Lens intended for single-use, and if so, what does that mean for handling and sterility?

  Yes, the AL-47 Soft Contact Lens is supplied as a single-use device, meaning each lens is intended for one-time wear only. Since it is non-sterile as supplied, users must sterilize the lens before use to ensure safety and hygiene. Proper handling and storage are essential to maintain the lens’s integrity and prevent contamination.

• How is the AL-47 Soft Contact Lens manufactured, and what does this process imply for its fit and comfort?

  The AL-47 Soft Contact Lens is lathe-cut and polished in its dry state before use. This precision manufacturing process ensures a smooth, accurate fit to the corneal curvature, which enhances comfort and optical clarity. Once immersed in an aqueous solution, the hydrophilic polymacon material becomes pliable, further adapting to the eye for a comfortable wearing experience.

• What regulatory pathway was followed for the AL-47 Soft Contact Lens, and what does this mean for its classification?

  The AL-47 Soft Contact Lens was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P820078. It is classified under product code LPL and falls under Class II regulatory standards, indicating it has undergone rigorous evaluation to ensure safety and effectiveness for daily wear contact lens applications.

• Are there any specific storage instructions for the AL-47 Soft Contact Lens, and how should it be stored before use?

  The AL-47 Soft Contact Lens should be stored in a clean, dry environment to maintain its integrity before use. Since it is non-sterile as supplied, it must be sterilized by the user prior to insertion. Proper storage ensures the lens remains free from contamination and retains its intended shape and clarity for optimal performance.