Chiroflex II Lens MicroSERT

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

Full name

Chiroflex II Lens Microsert(Tm)

510(k) Number

K914311 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K905825 Active Cleared 10 Jun 1991

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  FDA 510(k) K885015 Active Cleared 23 Jun 1989

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  FDA 510(k) K882762 Active Cleared 12 Sep 1988

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  FDA 510(k) K903575 Active Cleared 21 Dec 1990

• Optisol

  Unclassified

  FDA 510(k) K894162 Active Cleared 12 Jan 1990

See all devices from Chiron Ophthalmics →

• What is the Chiroflex II Lens MicroSERT used for during cataract surgery?

  The Chiroflex II Lens MicroSERT is a guide lens designed to assist surgeons in precisely positioning and stabilizing the primary intraocular lens during cataract surgery. Its purpose is to ensure accurate alignment of the lens within the eye, helping to improve the overall success and precision of the implantation process.

• Is the Chiroflex II Lens MicroSERT intended for single-use or reusable applications?

  The Chiroflex II Lens MicroSERT is explicitly supplied sterile and intended for single-use only in an operating room setting. This ensures patient safety and maintains sterility standards for surgical procedures.

• How is the Chiroflex II Lens MicroSERT regulated, and what classification does it fall under?

  The Chiroflex II Lens MicroSERT is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K914311). This classification reflects its role as an intraocular lens guide, which carries higher regulatory scrutiny due to its direct use in surgical procedures.

• Are there different sizes or models of the Chiroflex II Lens MicroSERT, and how would I identify compatibility with my surgical needs?

  The provided data does not specify distinct sizes or models of the Chiroflex II Lens MicroSERT, but it is designed to be compatible with standard surgical practices for intraocular lens implantation. Compatibility would depend on the primary intraocular lens being used, as the MicroSERT acts as a guide for that lens. Always verify compatibility with your specific surgical setup or consult the manufacturer’s instructions.

• How should the Chiroflex II Lens MicroSERT be stored before use?

  Since the Chiroflex II Lens MicroSERT is supplied sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility and functionality.