Soft Lens Products, LENS PLUS

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

Full name

Lens Plus(Tm)

Generic Name

Accessories, soft lens products

PMA Number

P820050 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

  Class II

  FDA 510(k) K050648 Active Cleared 5 Apr 2005

• The Amo Ophthalmic Surgical System

  Class II

  FDA 510(k) K060366 Active Cleared 7 Apr 2006

• Lens Plus Rewetting Drops

  Class II

  FDA 510(k) K042562 Active Cleared 29 Jul 2005

• Vitrectomy Cutter and Accessories

  Class II

  FDA 510(k) K081681 Active Cleared 8 Oct 2008

• Blink Cl Lubricant Eye Drops

  Class II

  FDA 510(k) K032030 Active Cleared 25 Sep 2003

• One Series Ultra Cartridge, Model 1VIPR30

  Class I

  FDA 510(k) K081545 Active Cleared 2 Oct 2008

See all devices from Advanced Medical Optics, Inc. →

• What is the LENS PLUS(TM) designed to improve about soft contact lenses, and how is it used?

  The LENS PLUS(TM) is designed to enhance the fit, comfort, or performance of soft contact lenses by improving lens stability, retention, or handling during application, removal, or storage. It is a reusable accessory intended for use in conjunction with soft contact lenses, meant to be used in clinical or home settings by trained professionals or supervised patients.

• Is the LENS PLUS(TM) sterile, and how should it be handled between uses?

  The LENS PLUS(TM) is not sterile and is intended for reusable clinical or home use. Since it is not sterile, proper cleaning and disinfection between uses are essential to maintain hygiene and prevent contamination. The regulatory data does not specify storage conditions, so standard ophthalmic hygiene practices should be followed.

• What regulatory pathway was followed for the LENS PLUS(TM), and what does that mean for its use?

  The LENS PLUS(TM) was authorized through the FDA’s Premarket Approval (PMA) pathway, specifically under PMA P820050 and Supplement S007. This means the device underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use as an accessory for soft contact lenses. Clinicians and users should confirm compliance with the approved labeling and follow manufacturer guidelines.

• Are there different sizes or models of the LENS PLUS(TM), and how would I identify the correct one for my practice?

  The regulatory data does not specify distinct sizes or models of the LENS PLUS(TM) in the provided details. However, the product is classified under Accessories, Soft Lens Products with a product code of LPN, indicating it is designed as a general reusable accessory for soft contact lenses. For precise sizing or model selection, refer to the manufacturer’s documentation or consult Advanced Medical Optics, Inc. to ensure compatibility with your specific lens types or patient needs.