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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser, ophthalmic
Regulation Description Ophthalmic laser.
Product CodeHQF
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLEX MEDICAL PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIDEK CO
  SUBSTANTIALLY EQUIVALENT 3
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OPHTHALMED LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TOPCON MEDICAL LASER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Laser 39
Adverse Event Without Identified Device or Use Problem 33
Device Operates Differently Than Expected 29
Unexpected Therapeutic Results 15
Insufficient Information 10
Output Problem 10
Device Operational Issue 8
Misfocusing 8
Output below Specifications 6
Power Problem 6
Failure to Fire 5
Loss of Power 4
Component or Accessory Incompatibility 3
Self-Activation or Keying 3
Appropriate Term/Code Not Available 3
Device Displays Incorrect Message 3
System 2
Device Inoperable 2
Calibration Problem 2
Inadequate User Interface 2
Protective Measures Problem 2
Energy Output Problem 2
Failure to Deliver Energy 2
Material Separation 2
Defective Device 1
Installation-Related Problem 1
Physical Property Issue 1
Protector 1
Energy Output To Patient Tissue Incorrect 1
Inadequate Instructions for Healthcare Professional 1
Switches 1
Use of Incorrect Control Settings 1
Application Program Problem 1
Improper Device Output 1
Device Handling Problem 1
Output above Specifications 1
Optical Fiber 1
Use of Device Problem 1
Environmental Particulates 1
Knife 1
No Apparent Adverse Event 1
Connection Problem 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Overheating of Device 1
Failure to Shut Off 1
Probe 1
Nonstandard device 1
Difficult to Remove 1
Manufacturing, Packaging or Shipping Problem 1
Inadequate or Insufficient Training 1
Suction Problem 1
Failure to Align 1
Total Device Problems 229

Recalls
Manufacturer Recall Class Date Posted
1 Laserex Systems Inc. II Apr-07-2016
2 Nidek Inc II Feb-19-2015
3 Topcon Medical Laser Systems, Inc II Aug-11-2016
4 Ziemer Usa Inc II Jan-15-2015

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