MONARCH II IOL DELIVERY SYSTEM— 510(k) K003768
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K003768 for MONARCH II IOL DELIVERY SYSTEM, Substantially Equivalent on 2001-01-05. Applicant: Alcon Research, Ltd.. Device class: 1.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Code MSS
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Fort Worth, TX, US
Recent devices under product code MSS
view allMore clearances from Alcon Research, Ltd.
view all- K161794 — CENTURION Vision System (Active SentryTM)
- K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
- K141065 — CONSTELLATION VISION SYSTEM
- K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505
- K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
Adverse events under product code MSS
product code MSS- Injury
- 385
- Malfunction
- 2,033
- Total
- 2,418
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.