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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tomography, optical coherence
Definition Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Product CodeOBO
Regulation Number 886.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
CANON INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEIDELBERG ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 5
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPTOMEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
OPTOS PLC
  SUBSTANTIALLY EQUIVALENT 2
OPTOVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOMEY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOPCON CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Unintended Electrical Shock 1 1
Improper or Incorrect Procedure or Method 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Disturbances 3 3
Vitreous Detachment 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Vitreous Floaters 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec, Inc. II Mar-04-2022
2 Carl Zeiss Meditec, Inc. II Aug-06-2021
3 Carl Zeiss Meditec, Inc. II Jan-02-2020
4 Haag-Streit USA Inc II Jan-10-2022
5 Heidelberg Engineering GmbH II Aug-30-2019
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