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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, ophthalmic, ac-powered
Product CodeHKI
Regulation Number 886.1120
Device Class 2


Premarket Reviews
ManufacturerDecision
C.S.O. S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CANON COMPONENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON, INC.-MEDICAL EQUIPMENT GROUP
  SUBSTANTIALLY EQUIVALENT 2
CENTERVUE SPA
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLARITY MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
CRYSTALVUE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EYENEZ LLC
  SUBSTANTIALLY EQUIVALENT 1
EYEQUICK.LLC
  SUBSTANTIALLY EQUIVALENT 1
FORUS HEALTH PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUNDUS PHOTO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HUVITZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMEDOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ISCREEN VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEELER LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KOWA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 5
KOWA COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
LUNEAU TECHNOLOGY OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEOLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT SIGHT SRL
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK TECHNOLOGIES SRL
  SUBSTANTIALLY EQUIVALENT 1
OPHTHALMIC IMAGING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OPTINA DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
OPTINA DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
OPTOMED OY
  SUBSTANTIALLY EQUIVALENT 5
OPTOMED OYJ
  SUBSTANTIALLY EQUIVALENT 1
OPTOVUE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHELCOM TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX TECHNOLOGY GROUP, INC. DBA PHOENIX CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
SOFTCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TEARSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 4
TOPCON CORP.
  SUBSTANTIALLY EQUIVALENT 4
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TOPCON MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRUEVISION SYSTEMS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
UNITED INTEGRATED SERVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASOPTIC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZILIA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 66 66
2017 20 20
2018 14 14
2020 5 5
2021 3 3
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 19 19
Device Issue 12 12
Operating System Becomes Nonfunctional 11 11
Loss of Data 10 10
Device Inoperable 8 8
Connection Problem 8 8
Device Operates Differently Than Expected 7 7
Computer Operating System Problem 6 6
Poor Quality Image 6 6
No Display/Image 5 5
Electrical /Electronic Property Problem 3 3
Image Resolution Poor 3 3
Computer Software Problem 3 3
Crack 3 3
No Device Output 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Displays Incorrect Message 3 3
Application Network Problem 3 3
Data Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Programming Issue 2 2
Patient Data Problem 2 2
Power Problem 2 2
Application Program Problem 2 2
Use of Device Problem 2 2
Misfocusing 2 2
Smoking 2 2
Corroded 2 2
Circuit Failure 1 1
Loose or Intermittent Connection 1 1
Device Stops Intermittently 1 1
Fumes or Vapors 1 1
Split 1 1
Date/Time-Related Software Problem 1 1
Device Sensing Problem 1 1
Electrical Power Problem 1 1
Environmental Compatibility Problem 1 1
Installation-Related Problem 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Problem with Software Installation 1 1
Operating System Version or Upgrade Problem 1 1
Optical Distortion 1 1
Optical Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Device Fell 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 63 63
No Consequences Or Impact To Patient 38 38
No Clinical Signs, Symptoms or Conditions 7 7
Not Applicable 4 4
No Information 2 2
Electric Shock 1 1
Bradycardia 1 1
Fatigue 1 1
Visual Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clarity Medical Systems Inc II Mar-20-2014
2 Clarity Medical Systems Inc II Mar-07-2014
3 Clarity Medical Systems Inc II Feb-24-2012
4 Merge Healthcare, Inc. II Feb-25-2019
5 Merge Healthcare, Inc. II Feb-06-2017
6 Merge Healthcare, Inc. II Jan-12-2017
7 Nidek Inc II Jul-02-2014
8 Nidek Inc II Aug-23-2013
9 Optovue, Inc. II Oct-04-2017
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