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) → MSS — Folders And Injectors, Intraocular Lens (Iol) # MSS · Folders And Injectors, Intraocular Lens (Iol) _Ophthalmic · 21 CFR 886.4300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS ## Overview - **Product Code:** MSS - **Device Name:** Folders And Injectors, Intraocular Lens (Iol) - **Regulation:** [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## 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 62) Showing 20 most recent of 62 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252540](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K252540.md) | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | Sep 16, 2025 | SESE | | [K242389](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K242389.md) | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | Oct 10, 2024 | SESE | | [K231106](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K231106.md) | Accuject Refra Injector AR2900 | Medicel AG | Sep 19, 2023 | SESE | | [K231838](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K231838.md) | RxSight® Insertion Device (63002) | Rxsight, Inc. | Aug 15, 2023 | SESE | | [K231466](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K231466.md) | RxSight Insertion Device | Rxsight, Inc. | Jun 12, 2023 | SESE | | [K212039](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K212039.md) | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | Aug 23, 2021 | SESE | | [K200057](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K200057.md) | bioli lOL Delivery System | Ast Products, Inc. | Jun 4, 2020 | SESE | | [K192926](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K192926.md) | RxSight Insertion Device | Rxsight, Inc. | Jan 17, 2020 | SESE | | [K192005](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K192005.md) | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | Oct 4, 2019 | SESE | | [K191949](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K191949.md) | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | Sep 13, 2019 | SESE | | [K182965](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K182965.md) | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | Mar 29, 2019 | SESE | | [K181401](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K181401.md) | RxSight Insertion Device | Rxsight, Inc. | Jul 26, 2018 | SESE | | [K172228](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K172228.md) | pioli IOL Delivery System | Ast Products, Inc. | Dec 15, 2017 | SESE | | [K173480](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K173480.md) | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | Dec 11, 2017 | SESE | | [K172375](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K172375.md) | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | Sep 6, 2017 | SESE | | [K161776](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K161776.md) | Lenstec LC Injection system | Lenstec, Inc. | Nov 29, 2016 | SESE | | [K161012](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K161012.md) | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | Jul 6, 2016 | SESE | | [K151102](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K151102.md) | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | May 22, 2015 | SESE | | [K143434](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K143434.md) | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | May 6, 2015 | SESE | | [K142056](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K142056.md) | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | Apr 9, 2015 | SESE | ## Top Applicants - Medicel AG — 5 clearances - Lenstec, Inc. — 5 clearances - Bausch & Lomb, Inc. — 5 clearances - Bausch & Lomb — 5 clearances - Staar Surgical Co. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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