Intraocular Lens Models PC10 & PC21

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

Full name

Models PC10 & PC21

Generic Name

intraocular lens

PMA Number

P820049 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

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• Are the PC10 and PC21 intraocular lenses reusable or designed for single-use only?

  The PC10 and PC21 intraocular lenses are explicitly designed for single-use only and are supplied sterile to ensure patient safety. Since they are classified as Class III devices under FDA regulations, their sterile packaging and intended single-use align with strict medical device standards to prevent cross-contamination and maintain efficacy.

• What are the key differences between the PC10 and PC21 models in terms of surgical placement?

  Both models are foldable, single-piece posterior chamber intraocular lenses, but their haptics and optical power options are tailored for different surgical needs. The PC10 and PC21 can be implanted either in the capsular bag or the ciliary sulcus, depending on the patient’s anatomy and surgical requirements. The specific design variations allow surgeons to choose based on factors like lens stability, accommodation, or anatomical constraints.

• How should these lenses be stored to maintain sterility and integrity before use?

  The PC10 and PC21 lenses must be stored and handled strictly per manufacturer instructions to preserve sterility and structural integrity. Since they are supplied sterile, the packaging should remain unopened until immediate preoperative use. Exposure to moisture, extreme temperatures, or contamination risks compromising their sterile state, so adherence to the provided storage guidelines is critical.

• What regulatory pathway was followed for FDA approval of these intraocular lenses?

  The PC10 and PC21 lenses require Premarket Approval (PMA) under FDA regulations, as they are classified as Class III devices. The approval process (PMA P820049) involved rigorous clinical and safety evaluations, including data submitted to the FDA’s Ophthalmic Devices Advisory Committee (OP). This pathway ensures the lenses meet stringent standards for safety and effectiveness before patient use.