Warning Letter: Failure to perform validation of device software (ucm402449)

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Ofni Systems

Failure to perform validation of device software, as required by 21 CFR § 820.30(g). Specifically, your firm failed to validate the software calculator for the STAAR Visian MICL Lens (ICL models MICL 12.1 mm, MICL 12.6 mm, MICL 13.2 mm, MICL 13.7 mm).

View the original warning letter.


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