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Instrumed International, Inc. recalls Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye
Recalled December 17, 2014 · FDA recall Z-0558-2015 · Instrumed International
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. · FDA Class II
Units
23 tonometers
Sold at
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Description
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Product
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.
Manufacturer(s)
Instrumed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →