MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)— 510(k) K112977

Substantially Equivalent

Alcon 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..

Clearance details

Applicant: Alcon Research, Ltd.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2011-10-06
Decision date: 2012-03-27
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, 2020-01-01 through 2026-04-23. 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.