American Optisurgical, Inc. - 4/19/2013
Issue Date
Apr 19, 2013
Region
Pacific
Category
Device
$117.00
Address 1
29602 Vista Terrace
City
Lake Forest
State
CA
Zip/Postal Code
92630
Country
United States
Inspection Range
Feb 12, 2013 - Apr 11, 2013
Pages
10
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Juanita Banuelos and Kimberly M. Lichter