Recall Z-0009-2018 ยท HKI Camera, Ophthalmic, Ac-Powered
Optovue, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic age
| Date | Jul 27, 2017 |
| Status | Terminated |
| Reason | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Root cause | Other |
| Action | Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240. |
| Quantity | 326 devices |
| Distribution | US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130656 | IFUSION Optovue, Inc., Jul 3, 2013 |