Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300) → KYB — Lens, Guide, Intraocular # KYB · Lens, Guide, Intraocular _Ophthalmic · 21 CFR 886.4300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB ## Overview - **Product Code:** KYB - **Device Name:** Lens, Guide, Intraocular - **Regulation:** [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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. ## Classification Rationale Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. ## Recent Cleared Devices (20 of 39) Showing 20 most recent of 39 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K152357](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K152357.md) | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | Oct 30, 2015 | SESE | | [K081382](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K081382.md) | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | Oct 23, 2008 | SESE | | [K072985](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K072985.md) | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | Jun 20, 2008 | SESE | | [K070669](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K070669.md) | IOL INJECTOR SET | Medicel AG | Nov 1, 2007 | SESE | | [K063155](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K063155.md) | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | Mar 27, 2007 | SESE | | [K063694](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K063694.md) | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | Mar 7, 2007 | SESE | | [K032412](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K032412.md) | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | Jun 10, 2004 | SESE | | [K022723](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K022723.md) | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | Dec 26, 2002 | SESE | | [K001157](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K001157.md) | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | Jun 27, 2000 | SESE | | [K983129](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K983129.md) | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | Dec 4, 1998 | SESE | | [K981571](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K981571.md) | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | Jul 9, 1998 | SESE | | [K970033](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K970033.md) | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | Apr 23, 1997 | SESE | | [K965185](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K965185.md) | ACRYPAK FOLDER | Alcon Laboratories | Mar 31, 1997 | SESE | | [K961242](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K961242.md) | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | Jun 17, 1996 | SESE | | [K954600](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K954600.md) | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | Dec 21, 1995 | SESE | | [K951292](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K951292.md) | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | Jun 2, 1995 | SESE | | [K930628](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K930628.md) | KLAAS IOL LENSFOLDER | Bova Intl. | Feb 7, 1995 | SESE | | [K940593](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K940593.md) | DISPOSABLE MICROSTAAR INJECTOR | Staar Sugical | Sep 19, 1994 | SESE | | [K941603](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K941603.md) | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE | Allergan Medical Optics | Jul 6, 1994 | SESE | | [K930320](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB/K930320.md) | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR | Allergan Medical Optics | Apr 7, 1994 | SESE | ## Top Applicants - Staar Surgical Co. — 6 clearances - Alcon Laboratories — 3 clearances - Duckworth & Kent, Ltd. — 2 clearances - CooperVision, Inc. — 2 clearances - Chiron Vision Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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