MONARCH IOL DELIVERY SYSTEM
K970033 · Alcon Laboratories · KYB · Apr 23, 1997 · Ophthalmic
Device Facts
| Record ID | K970033 |
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| Device Name | MONARCH IOL DELIVERY SYSTEM |
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| Applicant | Alcon Laboratories |
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| Product Code | KYB · Ophthalmic |
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| Decision Date | Apr 23, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 886.4300 |
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| Device Class | Class 1 |
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| Attributes | Therapeutic |
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Intended Use
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.
Device Story
System consists of reusable titanium handpiece and sterile, single-use cartridge; used for folding and delivering ACRYSOF® intraocular lenses into capsular bag during cataract surgery. Surgeon loads lens into cartridge; handpiece plunger, advanced via screw mechanism, expresses lens through cartridge into eye. Controlled delivery ensures lens unfolds completely without damaging lens geometry, haptic angle, power, or cosmetic attributes. Benefits include reliable, smooth lens placement during lens replacement procedures.
Clinical Evidence
Bench testing only. Performance data demonstrated successful delivery of ACRYSOF® IOLs without affecting lens length, haptic angle, power, resolution, or cosmetic attributes. Lenses unfolded completely within 30 seconds in a controlled manner.
Technological Characteristics
Materials: Reusable titanium handpiece, sterile single-use cartridge. Mechanism: Screw-driven plunger for controlled lens expression. Form factor: Handheld surgical instrument. Sterilization: Autoclavable handpiece, sterile cartridge.
Indications for Use
Indicated for patients undergoing cataract surgery requiring replacement of the human crystalline lens with an Alcon ACRYSOF® intraocular lens.
Regulatory Classification
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Predicate Devices
- ChiroFlex Lens Microsert™ (K903574)
- Softrans™ Injector (K913626)
Related Devices
- K151102 — Bausch + Lomb Injector System · Bausch & Lomb, Inc. · May 22, 2015
- K212039 — CLAREON MONARCH IV IOL Delivery System · Alcon Laboratories, Inc. · Aug 23, 2021
- K191949 — UNFOLDER Vitan Inserter · Johnson & Johnson Surgical Vision, Inc. · Sep 13, 2019
- K131958 — BAUSCH & LOMB INJECTOR SYSTEM · Bausch & Lomb · Jan 9, 2014
- K073010 — ROYALE AE 9036 LSP INJECTOR · Asico, LLC · Nov 7, 2007
Submission Summary (Full Text)
{0}
K970033
Alcon
LABORATORIES
APR 23 1997
ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY
FORT WORTH, TEXAS 76134-2099
(817) 293-0450
January 2, 1997
510(K) SUMMARY
Submitted by:
Martin A. Kaufman
Manager, Regulatory Affairs, Surgical Devices
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76132
(817) 551-8388 (Phone)
(817) 551-4630 (Fax)
Trade Name: MONARCH™ IOL Delivery System
Common Name: IOL Delivery System
Classification Name: Intraocular lens Guide, 21 CFR 886.4300
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{1}
K970633
## 1. Predicate Device
The legally marketed device(s) to which we are claiming equivalence to are:
a. K903574, ChiroFlex Lens Microsert™, (Chiron Ophthalmics Inc.)
b. K913626, Softrans™ Injector, (STAAR Surgical Company)
## 2. Device Description
The MONARCH™ IOL Delivery System consists of two parts: an autoclavable, reusable titanium handpiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF® intraocular lens into the capsular bag.
## 3. Intended Use of the Device
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.
## 4. Summary of the Technological Characteristics of the Device
The MONARCH™ IOL Delivery System utilizes a sterile, single use cartridge and a reusable handpiece to deliver ACRYSOF® lenses. The cartridge is designed for easy loading and reliable folding of ACRYSOF® lenses. The handpiece accepts the cartridge and delivers the lens by using a plunger to express the lens. The plunger head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by a screw mechanism to ensure a smooth and well controlled lens delivery.
## 5. Summary of the Performance Data
The performance test demonstrated that the MONARCH™ IOL Delivery System can be used to deliver ACRYSOF® IOLs without affecting the overall length, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely within 30 seconds in a controlled fashion.
## 6. Conclusions
The MONARCH™ IOL Delivery System is easy to use, properly delivers the Alcon ACRYSOF® intraocular lens, and is substantially equivalent to devices such as the Softrans™ Injector (Model ET) or the ChiroFlex Lens Microsert™ system.
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