Recall Z-1281-2013— Insight Instruments, Inc.
Class II · Terminated
Class II FDA medical device recall by Insight Instruments, Inc., initiated 2013-03-15, terminated 2014-08-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device..
- Recalling firm
- Insight Instruments, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-15
- Terminated
- 2014-08-21
- Firm location
- Stuart, FL, United States
Product description
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.
Reason for recall
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.