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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device keratome, ac-powered
Regulation Description Keratome.
Product CodeHNO
Regulation Number 886.4370
Device Class 1


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Suction Problem 4218
Adverse Event Without Identified Device or Use Problem 2685
Device Operates Differently Than Expected 119
Device Displays Incorrect Message 39
Scratched Material 33
Failure to Cut 25
Mechanical Problem 21
Appropriate Term/Code Not Available 10
Device Contamination with Chemical or Other Material 7
Energy Output Problem 5
Smoking 4
Noise, Audible 4
Failure to Advance 3
Optical Problem 2
Accessory Incompatible 2
Break 2
Retraction Problem 2
Computer Software Problem 2
Positioning Problem 2
Contamination During Use 2
Electrical /Electronic Property Problem 2
Therapy Delivered to Incorrect Body Area 2
Temperature Problem 2
Handpiece 1
Positioning Failure 1
Improper or Incorrect Procedure or Method 1
Expiration Date Error 1
Calibration Problem 1
Contamination / decontamination Problem 1
Decrease in Suction 1
Erratic or Intermittent Display 1
Reflux within Device 1
Electrical Shorting 1
Thermal Decomposition of Device 1
Poor Quality Image 1
Detachment of Device or device Component 1
Human-Device Interface Problem 1
Defective Component 1
Failure to Align 1
Power Problem 1
Insufficient Information 1
Use of Incorrect Control Settings 1
Device Expiration Issue 1
Gradient Increase 1
Expulsion 1
Mechanical Jam 1
Energy Output To Patient Tissue Incorrect 1
Sticking 1
Out-Of-Box Failure 1
Dent in Material 1
Failure to Power Up 1
Unintended Movement 1
Total Device Problems 7222

Recalls
Manufacturer Recall Class Date Posted
1 Med-logics Inc II Mar-13-2015

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