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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ophthalmic femtosecond laser
Regulation Description Ophthalmic laser.
Definition Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Product CodeOOE
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 4
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 2
ALCON
  SUBSTANTIALLY EQUIVALENT 3
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LENSAR, INC.
  SUBSTANTIALLY EQUIVALENT 7
OPTIMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TECHNOLAS PERFECT VISION GMBH
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Adverse Event Without Identified Device or Use Problem 324
Decrease in Suction 269
Device Operates Differently Than Expected 195
Insufficient Information 89
Laser 65
Suction Problem 57
System 49
Failure to Cut 37
Computer Software Problem 31
Failure to Align 20
Improper or Incorrect Procedure or Method 17
Device Displays Incorrect Message 17
Unintended Movement 12
Air Leak 12
Appropriate Term/Code Not Available 12
Detachment Of Device Component 11
Torn Material 8
Inadequacy of Device Shape and/or Size 7
Physical Property Issue 6
Break 6
Hole In Material 6
Material Rupture 5
Malposition of device 5
Patient-Device Incompatibility 4
Use of Device Problem 4
Positioning Problem 4
Gas Leak 4
Transmission Line 4
Material Fragmentation 3
Detachment of Device or device Component 3
Difficult to Open or Close 3
Unsealed Device Packaging 3
Leak / Splash 3
Loose or Intermittent Connection 3
Loss of or Failure to Bond 3
Interface 3
Thermal Decomposition of Device 2
Use of Incorrect Control Settings 2
Failure to Power Up 2
Cut In Material 2
Material Integrity Problem 2
Programming Issue 2
Data Problem 2
Noise, Audible 2
No Apparent Adverse Event 1
Temperature Probe 1
Radiation Overexposure 1
Therapeutic or Diagnostic Output Failure 1
Output Problem 1
Overcorrection 1
Misfire 1
Separation Failure 1
Improper Device Output 1
Compatibility Problem 1
Incorrect Device Or Component Shipped 1
Device Slipped 1
Problem with Sterilization 1
Sticking 1
Device Dislodged or Dislocated 1
Extrusion 1
Failure to Shut Off 1
Device Contamination with Chemical or Other Material 1
Device Markings / Labelling Problem 1
Off-Label Use 1
Product Quality Problem 1
Difficult to Remove 1
Self-Activation or Keying 1
Failure to Sense 1
Material Separation 1
Mechanical Problem 1
Migration or Expulsion of Device 1
Poor Quality Image 1
Energy Output Problem 1
Image Display Error / Artifact 1
Labelling, Instructions for Use or Training Problem 1
Display Difficult to Read 1
Crack 1
Failure to Cycle 1
Cylinder 1
IOL (Intraocular Lens) Implant 1
Lenses 1
Microscope 1
Scanner 1
Shutter 1
Total Device Problems 1360

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics, Inc. II Apr-23-2015
2 Alcon LenSx, Inc. II Apr-09-2014
3 Alcon Research, Ltd. II May-17-2016
4 Johnson & Johnson Surgical Vision Inc II Oct-03-2018
5 Optimedica Corporation II May-28-2015
6 Optimedica Corporation II Jan-08-2014
7 SIE AG, Surgical Instrument Engineering II Mar-29-2018

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