MONARCH II IOL DELIVERY SYSTEM— 510(k) K001157
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K001157 for MONARCH II IOL DELIVERY SYSTEM, Substantially Equivalent on 2000-06-27. Applicant: Alcon Research, Ltd.. Device class: 1.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Code KYB
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code KYB
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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 KYB
product code KYB- Injury
- 218
- Malfunction
- 1,989
- Other
- 1
- Total
- 2,208
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.