Z-1281-2013 Class II Terminated
FDA device recall Z-1281-2013 was initiated by Insight Instruments, Inc. on March 15, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 21, 2014). Affected quantity: 776.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- March 15, 2013
- Termination Date
- August 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 776
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.
Distribution Pattern
US Distribution IN and IL
Code Information
Lot Numbers: M53157, M55115, M56929, M58551, M61862.