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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
LENSX LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
OPTIMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 290
Device operates differently than expected 213
No Information 90
Unintended movement 50
Suction issue 41
Failure to cut 40
Failure to align 34
Computer software issue 31
Device displays error message 19
Decrease in suction 18
Improper or incorrect procedure or method 17
No code available 13
Air leak 12
Detachment of device component 11
Torn material 8
Size incorrect for patient 7
Use of Device Issue 7
Hole in material 6
Break 6
Material rupture 5
Malposition of device 5
Positioning Issue 4
Gas leak 4
Patient-device incompatibility 4
Loss of or failure to bond 3
Difficult to open or close 3
Loose or intermittent connection 3
Detachment of device or device component 3
Material fragmentation 3
Leak 3
Poor quality image 3
Use of Incorrect Control Settings 2
Cut in material 2
Noise, Audible 2
Failure to sense 2
Output energy incorrect 2
Material integrity issue 2
Radiation Overexposure 1
Product quality issue 1
Display misread 1
Ambient temperature issue 1
Improper device output 1
Incompatibility problem 1
Failure to sterilize 1
Migration of device or device component 1
Difficult to remove 1
Dislodged or dislocated 1
Overcorrection 1
Not Applicable 1
Therapeutic or diagnostic output failure 1
Extrusion 1
Self-activation or keying 1
Misfire 1
Failure to shut off 1
Crack 1
Instruction for use issue 1
Mechanical issue 1
Slippage of device or device component 1
Material separation 1
Failure to separate 1
Image display error 1
Sticking 1
Foreign material present in device 1
Incorrect device or component shipped 1
Total Device Problems 995

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 2 2 1
Class III 0 0 0 0 0 0 0 0 0 0

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 Optimedica Corporation II May-28-2015
5 Optimedica Corporation II Jan-08-2014

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