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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biomicroscope, slit-lamp, ac-powered
Regulation Description AC-powered slitlamp biomicroscope.
Product CodeHJO
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 5
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 5
CHONGQING KANGHUA RUIMING S&T CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KEELER LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU KANGJIE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
TAKAGI SEIKO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 26
Output Problem 8
Incorrect Measurement 8
Use of Device Problem 8
Insufficient Information 7
Calibration Problem 3
Appropriate Term/Code Not Available 2
Manufacturing, Packaging or Shipping Problem 2
Programming Issue 2
Incorrect, Inadequate or Imprecise Resultor Readings 2
Data Problem 1
Device Handling Problem 1
Device Operates Differently Than Expected 1
Patient Data Problem 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 73

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Oct-15-2018
2 Carl Zeiss Meditec AG II Dec-01-2015
3 Nidek Inc II Aug-18-2016

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