62 results
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35ms
·
Sources: EU EUDAMED, US FDA
AcuFocus, Inc.
Manufacturer
🇺🇸 United States·2 Importers
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·October 2, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 24, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·October 2, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 4, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 25, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 24, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·January 5, 2016
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 4, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·December 4, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 24, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 4, 2015
KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
FDA Recall
Terminated
·AcuFocus, Inc.·Product code LQE·February 11, 2016
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 24, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 9, 2015
KAMRA CORNEAL INLAY
FDA Adverse Event
Injury
·CORNEAGEN·Product code LQE·October 4, 2018
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·November 5, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·October 15, 2015
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·October 21, 2016
KAMRA
FDA Adverse Event
Injury
·ACUFOCUS, INC.·Product code LQE·December 7, 2016