MONARCH II IOL DELIVERY SYSTEM
Device Facts
| Record ID | K003768 |
|---|---|
| Device Name | MONARCH II IOL DELIVERY SYSTEM |
| Applicant | Alcon Research, Ltd. |
| Product Code | MSS · Ophthalmic |
| Decision Date | Jan 5, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
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.