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Model P13 Modified C Loop Posterior Chamber Intraocular Lens

FDA PMA

Class III (US FDA PMA)

PMA P880072

by Eyekon Medical, Inc.

Identity

Trade Name
MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P880072 FDA PMA
FDA Product Code
HQL FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.3600 FDA PMA
Regulation Number
886.3600 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

This device is a Posterior Chamber Intraocular Lens (IOL), classified as a Class III medical device under FDA regulations. It is designed to replace the natural lens of the eye following cataract surgery or other conditions requiring lens removal, restoring vision by focusing light onto the retina. The Modified C Loop design ensures secure positioning within the eye’s posterior chamber while minimizing potential complications such as iris irritation or dislocation.

The Model P13 is supplied sterile and intended for single-use in ophthalmic surgical settings. It is manufactured by Eyekon Medical, Inc., and holds an FDA Premarket Approval (PMA) under PMA number P880072, adhering to regulatory requirements for intraocular implants. Available in a standardized design for posterior chamber placement, it requires aseptic handling and proper surgical technique for implantation. Storage must comply with sterile packaging guidelines to maintain integrity prior to use.

Frequently asked questions

What is the primary purpose of the Model P13 Modified C Loop Posterior Chamber IOL, and how does its design differ from standard IOLs?

The Model P13 Modified C Loop Posterior Chamber IOL is designed to replace the natural lens of the eye after cataract surgery or other conditions requiring lens removal. Its **Modified C Loop** design ensures secure positioning in the posterior chamber while minimizing complications like iris irritation or dislocation, which can occur with less optimized loop configurations. This design helps maintain stability and reduce potential postoperative issues.

Is the Model P13 IOL intended for reuse, or is it meant to be used only once per patient?

The Model P13 IOL is explicitly **intended for single-use only** in ophthalmic surgical settings. This aligns with standard sterile medical device practices to prevent cross-contamination and ensure patient safety. Each unit is supplied sterile and must not be reused.

How should the Model P13 IOL be stored before use, and what precautions must be taken?

The Model P13 IOL must be stored according to the **sterile packaging guidelines** provided by Eyekon Medical to maintain its integrity before use. Since it is sterile upon packaging, it should remain unopened and protected from contamination until implantation. Proper aseptic handling is critical to avoid compromising sterility.

What regulatory approval does the Model P13 Modified C Loop IOL hold, and how does this affect its use?

The Model P13 IOL holds an **FDA Premarket Approval (PMA)** under PMA number **P880072**, confirming it meets stringent regulatory requirements for Class III intraocular implants. This approval ensures the device’s safety and effectiveness for posterior chamber placement, but clinicians must still follow surgical best practices and adhere to the manufacturer’s instructions for proper use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Eyekon Medical, Inc.

Sources (1)

  • FDA PMA P880072 23 fields · synced Sep 18, 2026