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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
CYLITE PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
KOWA COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 19 19
2021 14 14
2022 6 6
2023 18 18
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 27 27
Adverse Event Without Identified Device or Use Problem 14 14
Insufficient Information 13 13
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Incorrect Measurement 9 9
Patient Data Problem 6 6
Output Problem 4 4
Device Fell 2 2
Calibration Problem 2 2
Application Program Version or Upgrade Problem 1 1
High Readings 1 1
Operating System Version or Upgrade Problem 1 1
Battery Problem 1 1
Misassembly During Maintenance/Repair 1 1
Device Difficult to Program or Calibrate 1 1
Data Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Self-Activation or Keying 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 62 62
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Eye / Vision Problem 2 2

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