Optovue, Inc.: iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo i

Is my product affected?

iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular struc

• UPC 00858848006056
• UPC 00858848006070
• UPC 00858848006216

Check against the official notice below — it lists the full affected range.

What happened

Optovue, Inc. is recalling 326 iVue imaging devices distributed nationwide across 38 states. The iVue is a non-contact, high-resolution tomographic imaging device used for in vivo imaging. The recall was initiated because the FDA determined that the Vault Mapping software (also known as Lens Fitting) requires a 510(k) submission, which is a type of regulatory approval that had not been obtained.

The affected devices can be identified by their catalog numbers, which include 700-45575, 700-45575-002, 700-45575-A, 700-47818-001 through 004, 700-47827-002, 700-47827-004, 700-47827-005, and 700-49007-002 through 003. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

Details from the source

Reason for recall: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). 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. Quantity: 326 devices Lot/code info: Cat No. 700-45575 (GTIN - N/A), 700-45575-002 (GTIN - N/A), 700-45575-A (GTIN - N/A), 700-47818-001 (GTIN - N/A), 700-47818-002 (GTIN - N/A), 700-47818-003 (GTIN - N/A), 700-47818-004 (GTIN 00858848006056), 700-47827-002 (GTIN - N/A), 700-47827-004 (GTIN - N/A), 700-47827-005 (GTIN 00858848006070), 700-49007-002 (GTIN - N/A), 700-49007-003 (GTIN 00858848006216).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 digit2017-07-27
• iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion ce2017-07-27
• VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip2017-07-27
• A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .2017-07-27
• A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.2017-07-27

All FDA (Device enforcement) recalls