MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)— 510(k) K112977
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K112977 for MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4), Substantially Equivalent on 2012-03-27. 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
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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 →
Recalls naming K112977
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112977.
Data sourced from openFDA. This site is unofficial and independent of the FDA.