Sauflon PW (Lidofilcon B)

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

Full name

Sauflon(R) Pw (Lidofilcon B)

Trade Name

Sauflon(R) 70 (Lidofilcon a)

Generic Name

Lenses, soft contact, extended wear

PMA Number

P790020 ↗

FDA Product Code

LPM

Device Class

Class III

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

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See all devices from Advanced Medical Optics, Inc. →

• Are these contact lenses designed for daily wear or extended use, and how does that differ from typical soft contact lenses?

  The Sauflon PW (Lidofilcon B) lenses are specifically designed for **extended wear**, meaning they are intended for continuous or prolonged use—typically overnight or for extended periods—while maintaining corneal oxygenation. Unlike daily-wear lenses, which are removed at night, these lenses are engineered to provide comfort and visual clarity over longer durations, making them suitable for patients who require extended corneal oxygenation without frequent removal.

• Are the Sauflon PW lenses single-use or reusable, and how should they be handled to maintain sterility?

  The Sauflon PW lenses are **sterile, single-use only**, meaning each lens is intended for one-time wear and must not be reused. To preserve sterility, they come in sealed packaging that should remain unopened until use. After opening, the lens should be handled with clean, dry hands or sterile tools, and any unused portion must be discarded to avoid contamination or infection risks.

• What regulatory pathway was followed for approval of the Sauflon PW lenses, and what does that mean for clinicians or buyers?

  The Sauflon PW lenses were approved through the **FDA Premarket Approval (PMA) process**, a rigorous pathway for Class III medical devices. This means the device underwent extensive clinical testing and review to ensure safety and effectiveness for extended wear. Clinicians or buyers can rely on this approval as evidence of the lens’s compliance with stringent regulatory standards for ophthalmic use.

• How do I determine the correct size or model of Sauflon PW lenses for a patient, and are there multiple options available?

  The Sauflon PW lenses are categorized under the **generic name