← Product Code [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS) · K003768

# MONARCH II IOL DELIVERY SYSTEM (K003768)

_Alcon Research, Ltd. · MSS · Jan 5, 2001 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K003768

## Device Facts

- **Applicant:** Alcon Research, Ltd.
- **Product Code:** [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS.md)
- **Decision Date:** Jan 5, 2001
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 886.4300
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K003768](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K003768)

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