Recall Z-0144-2014 ยท HNJ Punch, Corneo-Scleral
Insight Instruments, Inc.
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
| Date | Nov 4, 2013 (initiated Jun 27, 2013) |
| Status | Terminated |
| Reason | The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance. |
| Root cause | No Marketing Application |
| Action | Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393. |
| Quantity | 10212 |
| Distribution | Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.