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Insight Instruments, Inc. recalls Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while s
Recalled May 22, 2013 · FDA recall Z-1281-2013 · Insight Instruments
Hazard
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device. · FDA Class II
Units
776
Sold at
US Distribution IN and IL
Description
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
Product
Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
Manufacturer(s)
Insight Instruments, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →