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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 302
Device operates differently than expected 214
No Information 90
Unintended movement 50
Suction issue 41
Failure to cut 40
Failure to align 34
Decrease in suction 32
Computer software issue 31
Device displays error message 21
Improper or incorrect procedure or method 17
No code available 13
Air leak 12
Detachment of device component 11
Torn material 8
Use of Device Issue 7
Size incorrect for patient 7
Hole in material 6
Break 6
Material rupture 5
Malposition of device 5
Patient-device incompatibility 4
Gas leak 4
Positioning Issue 4
Detachment of device or device component 3
Difficult to open or close 3
Material fragmentation 3
Loss of or failure to bond 3
Leak 3
Loose or intermittent connection 3
Poor quality image 3
Output energy incorrect 2
Use of Incorrect Control Settings 2
Failure to sense 2
Cut in material 2
Material integrity issue 2
Noise, Audible 2
Not Applicable 1
Radiation Overexposure 1
Therapeutic or diagnostic output failure 1
Dislodged or dislocated 1
Extrusion 1
Failure to shut off 1
Foreign material present in device 1
Ambient temperature issue 1
Overcorrection 1
Improper device output 1
Incompatibility problem 1
Incorrect device or component shipped 1
Misfire 1
Failure to separate 1
Material separation 1
Self-activation or keying 1
Image display error 1
Instruction for use issue 1
Slippage of device or device component 1
Failure to sterilize 1
Sticking 1
Crack 1
Display misread 1
Product quality issue 1
Difficult to remove 1
Mechanical issue 1
Migration of device or device component 1
Total Device Problems 1024

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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