Models 011 & 011B Iridocapsular IOLs

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

intraocular lens

PMA Number

P810042 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

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• What is the primary purpose of the Models 011 & 011B Iridocapsular IOLs, and how do they function in cataract surgery?

  The Models 011 & 011B Iridocapsular IOLs are designed to replace the natural lens of the eye following cataract surgery. They are implanted within the capsular bag to restore visual function by providing optical correction for aphakia (absence of a lens). These lenses maintain alignment within the capsular structure, ensuring stable positioning for clear vision.

• Are the Models 011 & 011B Iridocapsular IOLs intended for reuse, or are they single-use devices?

  The Models 011 & 011B Iridocapsular IOLs are explicitly labeled as intended for single-use in ophthalmic surgical settings. This designation ensures sterility and safety for each patient, reducing the risk of infection or contamination.

• How were these devices authorized for use in the United States, and what regulatory classification do they hold?

  The Models 011 & 011B Iridocapsular IOLs were authorized via a Premarket Approval (PMA) application (PMA Number: P810042) by the FDA. They are classified as Class III devices, which is the highest regulatory classification for medical devices requiring a rigorous approval process due to their critical role in patient safety and effectiveness.

• What storage conditions should be considered for these intraocular lenses, and are they provided sterile?

  The Models 011 & 011B Iridocapsular IOLs are supplied sterile, ensuring they are ready for immediate use in surgical settings. However, the provided data does not specify detailed storage conditions, so it is important to follow manufacturer guidelines or best practices to maintain sterility and integrity until use.