FDA Puts Import Alert on Imaging Products From Canadian Company

The FDA has placed an import alert on several imaging products made by Canadian firm Ophthalmic Technologies, citing several quality system and medical device-reporting violations. The agency issued the company a warning letter in March.

Given the “serious nature of the violations,” the firm’s ophthalmic ultrasounds OTI Scan 1000, OTT Scan 2000 and OTI OCT/SLO may be refused admission into the United States until the violations are corrected. 

View the warning letter at www.fda.gov/foi/warning_letters/s7011c.htm. 

Ophthalmic Technologies Inc. provides technologically advanced diagnostic products to assist ophthalmologists and physicians in the detection, treatment and management of ophthalmic disease.