← Product Code [KYB](/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB) · K970033 # MONARCH IOL DELIVERY SYSTEM (K970033) _Alcon Laboratories · KYB · Apr 23, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K970033 ## Device Facts - **Applicant:** Alcon Laboratories - **Product Code:** [KYB](/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB.md) - **Decision Date:** Apr 23, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4300 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## 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. ## Regulatory 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](/device/K903574.md)) - Softrans™ Injector ([K913626](/device/K913626.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 76 {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. 77 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K970033](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K970033) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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