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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
CYLITE PTY. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOWA COMPANY , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 14 14
2022 6 6
2023 18 18
2024 18 18
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 23 23
Adverse Event Without Identified Device or Use Problem 18 18
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Misassembly During Maintenance/Repair 11 11
Insufficient Information 9 9
Incorrect Measurement 8 8
High Readings 4 4
Patient Data Problem 2 2
Calibration Problem 2 2
Application Program Version or Upgrade Problem 1 1
Operating System Version or Upgrade Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Low Readings 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 60 60
No Clinical Signs, Symptoms or Conditions 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Eye / Vision Problem 2 2
Insufficient Information 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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