Recall Z-1281-2013 ยท HMX Cannula, Ophthalmic
Insight Instruments, Inc.
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
| Date | May 10, 2013 (initiated Mar 15, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots. |
| Quantity | 776 |
| Distribution | US Distribution IN and IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.