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Alcon Research, Ltd.
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MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) is an FDA 510(k)-cleared medical device (K112977) manufactured by Alcon Research, Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 26, 2012. Regulation: 8.