Z-2202-2013Class II

Sonogage EyeScan, A-Scan Biometer

Name: Z-2202-2013 Sonogage EyeScan, A-Scan Biometer
Creator: Sonogage Inc
Published: 2013-08-09
License: https://open.fda.gov/license/

Sonogage, Inc. / initiated 2013-08-09 / Terminated

FDA source

Sonogage Inc began a recall of Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length on 2013-08-09. FDA classified it as Class II and gives the reason as "During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2202-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-09
Posted: 2013-09-16
Terminated: 2015-09-19
Recalling firm: Sonogage, Inc.
Product: Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
FDA root cause: No Marketing Application
Action: Sonogage sent an Urgent: Medical Device Recall letter dated August 9, 2013 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine inventory and quarantine the affected product for return. Customers were asked to complete and return the enclosed response form. For question call 216-464-1119 or 800-798-1119.
Quantity in commerce: 564 units
Distribution: Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.
Product codes and lots: Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2202-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-16

Product code IYO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)