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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-01-24NAINo action indicatedNidek, Inc.0
2019-01-24NAINo action indicatedNidek, Inc.0
2017-03-31NAINo action indicatedNidek, Inc.0
2017-03-31NAINo action indicatedNidek, Inc.0
2016-08-10NAINo action indicatedNidek, Inc.0
2016-08-10NAINo action indicatedNidek, Inc.0
2015-06-10VAIVoluntary action indicatedNidek, Inc.1
2015-06-10VAIVoluntary action indicatedNidek, Inc.1
2014-08-08WLWarning LetterNidek, Inc.—
2014-08-08WLWarning LetterNidek, Inc.—
2014-07-31VAIVoluntary action indicatedNIDEK Co., Ltd.6
2014-07-31VAIVoluntary action indicatedNIDEK Co., Ltd.6
2014-04-14OAIOfficial action indicatedNidek, Inc.10
2014-04-14OAIOfficial action indicatedNidek, Inc.10
2013-09-24WLWarning LetterNIDEK Co., Ltd.—
2013-09-24WLWarning LetterNIDEK Co., Ltd.—
2013-07-30VAIVoluntary action indicatedNidek, Inc.7
2013-07-30VAIVoluntary action indicatedNidek, Inc.7
2012-03-07VAIVoluntary action indicatedNidek, Inc.3
2012-03-07VAIVoluntary action indicatedNidek, Inc.3
2010-02-18NAINo action indicatedNIDEK Co., Ltd.0
2010-02-18NAINo action indicatedNIDEK Co., Ltd.0
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