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.
Z-1281-2013
Product summary
- Event
- Event 64887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 776
- Official record key
device-enforcement:Z-1281-2013
Official wording
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.
Code information: Lot Numbers: M53157, M55115, M56929, M58551, M61862.
Distribution pattern: US Distribution IN and IL
Derived failure modes
-
Unknown
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.