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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
Product CodeHJO
Regulation Number 886.1850
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO LTD
  SUBSTANTIALLY EQUIVALENT 1
KOWA COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 11 11
2019 13 13
2020 19 19
2021 14 14
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 11 11
Use of Device Problem 10 10
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Output Problem 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Patient Data Problem 6 6
Calibration Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Fell 2 2
Product Quality Problem 1 1
Battery Problem 1 1
Power Problem 1 1
Data Problem 1 1
Device Handling Problem 1 1
Device Difficult to Program or Calibrate 1 1
Self-Activation or Keying 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 37 37
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 5 5
No Code Available 4 4
Blurred Vision 1 1
Visual Disturbances 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Feb-18-2021
2 Carl Zeiss Meditec AG II Oct-15-2018
3 Haag-Streit USA Inc II May-11-2021
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