Opus - III Contact Lenses

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

Generic Name

Lens, contact (other material) - daily

PMA Number

P820074 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

• Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

  Class II

  FDA 510(k) K991000 Active Cleared 28 Jun 1999

• Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)C

  Class II

  FDA 510(k) K000439 Active Cleared 20 Mar 2000

• Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K994335 Active Cleared 20 Mar 2000

• Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

  Class II

  FDA 510(k) K993935 Active Cleared 21 Dec 1999

• Precision UV (Vasurfilcon a)

  Class II

  FDA 510(k) K982988 Active Cleared 6 Jan 1999

• Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint

  Class II

  FDA 510(k) K954603 Active Cleared 4 Jan 1996

See all devices from Wesley Jessen Corp. →

• Are the Opus-III Contact Lenses intended for extended wear or daily use only?

  The Opus-III Contact Lenses are explicitly designed for single-day wear only, as stated in the description. They are classified as daily-use contact lenses and are not intended for overnight or extended wear. This aligns with standard disposable contact lens guidelines to ensure patient safety and comfort.

• How should I store the Opus-III Contact Lenses before use, and are they sterile?

  The Opus-III Contact Lenses are non-sterile and must be stored and handled according to standard ophthalmic contact lens protocols. Since they are single-use, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until use. Always follow manufacturer instructions for proper storage to maintain device integrity.

• What regulatory pathway was followed for the approval of the Opus-III Contact Lenses?

  The Opus-III Contact Lenses were approved through the FDA Premarket Approval (PMA) process, with PMA number P820074. This pathway is typically used for higher-risk medical devices, and the product falls under device class II with the product code HQD. The approval was granted in 1984, as indicated in the submission records.

• Are there multiple sizes or models available for the Opus-III Contact Lenses, and how are they differentiated?

  While the provided data does not specify exact sizes or models in detail, the Opus-III Contact Lenses are categorized under FDA’s generic name ‘Lens, contact (other material) - daily’, which implies they are designed to correct refractive errors like myopia or hyperopia. The OpenFDA registration numbers suggest multiple FEI (Firm Establishment Identifier) entries, which may correlate to different lot batches or variations in prescription strengths. For precise sizing or model details, refer to the manufacturer’s labeling or product documentation.