Ocufilcon B Lenses

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

Full name

Sterilized Finished Ocufilcon B Lenses

Trade Name

Ocu-Flex

Generic Name

Lenses, soft contact, daily wear

PMA Number

P820051 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• Ocu-Flex-38 (Polymacon)

  Class II

  FDA 510(k) K941998 Active Cleared 13 Oct 1994

• Ocu-Flex-49 Thin Zone Toric and Thin Z0NE Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily Wear (Lathe-Cut

  Class II

  FDA 510(k) K004000 Active Cleared 21 Feb 2001

• Tinted Ocu-Flex 53 (Occufilcon B) Soft Hydrophilic Contact Lens

  Class II

  FDA 510(k) K960291 Active Cleared 25 Mar 1996

• Ocu-Flex-49 Spherical, Toric, Aspherical and Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily Wear

  Class II

  FDA 510(k) K002966 Active Cleared 8 Nov 2000

• Ocu-Flex-38 Keratoconus (Polymacon) Soft Contact Lens for Daily Wear

  Class II

  FDA 510(k) K992466 Active Cleared 4 Oct 1999

• Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens

  Class II

  FDA 510(k) K020690 Active Cleared 26 Apr 2002

See all devices from Ocu-Ease Optical Products, Inc. →

• Are these contact lenses designed for extended wear or daily wear only, and how does that affect their usage guidelines?

  These lenses are explicitly designed for daily wear only, meaning they are intended to be worn for a single day and then discarded. The manufacturer specifies single-use per lens, ensuring optimal hygiene and safety. Unlike extended-wear lenses, these are not approved for overnight use, so adherence to daily removal and replacement is critical to maintain eye health and clarity.

• What storage and handling conditions must be followed to maintain the sterility of these lenses?

  The lenses are supplied in a sterile, finished form, so they must be stored and handled under sterile conditions to preserve their integrity. This includes keeping them in their original packaging until use, avoiding contamination, and following the manufacturer’s guidelines for storage temperature and humidity. Improper handling could compromise sterility and pose risks to the patient’s eye health.

• What does the FDA Premarket Approval (PMA) process entail for these lenses, and how does it impact their regulatory status?

  These lenses underwent the FDA Premarket Approval (PMA) process, which is a rigorous review to ensure their safety and effectiveness for correcting refractive errors. The PMA number P820051 and product code LPL confirm their regulatory clearance under this route. This means the device has been thoroughly evaluated by the FDA for clinical performance and compliance with applicable standards before being authorized for commercial distribution.

• Are these lenses available in multiple sizes or models, and if so, how can a clinician determine the correct fit for a patient?

  While the provided data lists multiple FEI numbers (e.g., 3015533540, 3012546757), these are administrative identifiers rather than direct size or model specifications. Clinicians should rely on the manufacturer’s sizing charts or fitting guides, which align with the Ocufilcon B material properties, to determine the appropriate lens diameter and base curve for each patient’s eye. Proper fitting is essential for comfort and visual clarity.

• How does the trade name *OCU-FLEX* relate to the product’s intended use, and does it imply any specific features beyond the generic description?

  The trade name *OCU-FLEX* does not provide additional clinical details beyond what’s stated in the generic description—these are soft contact lenses for daily wear made from Ocufilcon B material. The name likely emphasizes flexibility or comfort, which are common marketing attributes for soft lenses, but no specific features (e.g., UV protection, special coatings) are implied in the provided data. Clinicians should confirm any additional claims with the manufacturer.