Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer

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

510(k) Number

K980418 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint

  Class II

  FDA 510(k) K964528 Active Cleared 7 Mar 1997

• Extreme H20 (Hioxifilicon a) Soft Contact Lens

  Class II

  FDA 510(k) K992692 Active Cleared 18 Oct 1999

• Benz-Mf (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens (Lathe-Cut)

  Class II

  FDA 510(k) K003861 Active Cleared 8 Mar 2001

• Benz 38 Clear & with Blue Visibility Tint

  Class II

  FDA 510(k) K961103 Active Cleared 23 Aug 1996

• Benz-G 4X (Hioxifilcon D) Multifocal Lathed Lens

  Class II

  FDA 510(k) K101122 Active Cleared 9 Aug 2010

• (Lenses)Benz Hefilcon a Spherical/Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue or Light Green Visibi

  Class II

  FDA 510(k) K972807 Active Cleared 15 Oct 1997

See all devices from Benz Research and Development LLC →

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

  These lenses are explicitly labeled for daily wear only, meaning they are intended to be worn for short-term correction of visual acuity and are not designed for continuous or overnight use. The description specifies they are classified under *Lenses, Soft Contact, Daily Wear* and are not marketed for extended wear.

• How are these lenses supplied, and are they pre-packaged for single-use or reusable?

  The lenses are supplied as single-use items and are non-sterile at the time of distribution. Each lens is intended for one-time wear, after which it should be discarded. There is no indication of a reprocessing or reuse protocol in the provided data.

• What types of prescriptions do these lenses accommodate, and are there specific models for spherical or toric prescriptions?

  These lenses include both spherical and toric designs, meaning they can correct common refractive errors (spherical prescriptions) as well as astigmatism (toric prescriptions). The device is described as *Benz Methafilcon A spherical and toric soft (hydrophilic) contact lenses*, and the wide range of FEI numbers suggests multiple configurations to match various prescriptions.

• How should these lenses be stored before use, and are there any special handling instructions?

  The data does not specify storage conditions beyond the fact that they are non-sterile and supplied for single-use. Generally, soft contact lenses should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Since no sterility or MRI safety specifications are provided, users should follow standard ophthalmic practices for handling non-sterile contact lenses.