Device (019B +5 more) - 019K

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

Generic Name

intraocular lens

PMA Number

P810055 ↗

FDA Product Code

HQL

Models / Variants

019B

019C

019E

019F

019J

019K

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

• Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

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• The Amo Ophthalmic Surgical System

  Class II

  FDA 510(k) K060366 Active Cleared 7 Apr 2006

• Lens Plus Rewetting Drops

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  FDA 510(k) K042562 Active Cleared 29 Jul 2005

• Vitrectomy Cutter and Accessories

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  FDA 510(k) K081681 Active Cleared 8 Oct 2008

• Blink Cl Lubricant Eye Drops

  Class II

  FDA 510(k) K032030 Active Cleared 25 Sep 2003

• One Series Ultra Cartridge, Model 1VIPR30

  Class I

  FDA 510(k) K081545 Active Cleared 2 Oct 2008

See all devices from Advanced Medical Optics, Inc. →

• Are these intraocular lenses reusable or intended for single-use only?

  These intraocular lenses (Models 019B, 019C, 019E, 019F, 019J, and 019K) are explicitly designed for **single-use implantation** during ophthalmic procedures. The manufacturer, Advanced Medical Optics, Inc., supplies them sterile for one-time surgical use only, ensuring patient safety and compliance with sterile field protocols in controlled environments.

• How are these lenses stored, and what should clinicians consider before use?

  The lenses are supplied **sterile** and must be stored according to the manufacturer’s instructions to maintain integrity. Since they are single-use, clinicians should verify the packaging is intact and unopened before use. Proper storage conditions (e.g., dry, protected from light, and within expiration dates) are critical to preserve sterility and functionality. Always follow the included storage guidelines to avoid contamination or degradation.

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

  These lenses were approved via the **FDA Premarket Approval (PMA) process**, specifically under PMA number **P810055**. The device falls under **product code HQL** and is classified as a **Class III** medical device, requiring rigorous clinical and safety evaluations before approval. This pathway ensures the lenses meet stringent standards for restoring visual function and correcting refractive errors.

• Are there different models available, and if so, how do they differ?

  Yes, there are **six distinct models** (019B, 019C, 019E, 019F, 019J, and 019K) listed for these intraocular lenses. While the data provided does not specify exact differences in optical power, design, or refractive correction, the models are likely tailored for varying clinical needs such as aphakia correction, astigmatism management, or specific patient anatomies. Consult the manufacturer’s technical documentation for precise model-specific details, as these distinctions are critical for surgical planning.

• What should a buyer or hospital verify before purchasing these lenses?

  Before purchasing, buyers should confirm the **sterility status** of the packaging and verify the **expiration date** to ensure the lenses are within their usable range. Additionally, they should confirm compatibility with their surgical equipment and procedures, as well as check that the lenses align with their facility’s **ophthalmic protocols** for cataract surgery or lens replacement. Since these are **single-use**, inventory management should account for surgical volume and turnover rates.