Euclid Systems – contacts 4/12/00

The devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods “used in, or the facilities or controls used in the manufacture, processing, packaging, storage, or distribution of Orthokeratology (itaflurofocon B), toric, and aspheric contact lenses, are not in conformance with the Quality System Regulation for Medical Devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:

Failure to maintain adequate process validation documentation, in that there was no validation protocol or complete documentation for the software used to produce contact lenses, including the reverse geometry design algorithms, email/text to programmable lathe controller data input, and lathe operation and calibration software.

Failure to document that lens manufacturing equipment is appropriately constructed, placed, and installed (e.g., failure to document Installation, Operational, or Performance Qualifications for the _____ lathes used to manufacture contact lenses).

Baltimore District