MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)— 510(k) K101774

Substantially Equivalent

Alcon Manufacturing, Ltd.

FDA 510(k) clearance K101774 for MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4), Substantially Equivalent on 2011-10-13. Applicant: Alcon Manufacturing, Ltd..

Clearance details

Applicant: Alcon Manufacturing, Ltd.
Product code: Code MSS
Advisory panel: Ophthalmic
Date received: 2010-06-24
Decision date: 2011-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
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.