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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, soft lens products
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 3
ALCON
  SUBSTANTIALLY EQUIVALENT 16
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 12
ALTAIRE PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 16
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 15
OPTIKEM INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 4
SZABOCSIK AND ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 445
No Known Device Problem 410
Other (for use when an appropriate device code cannot be identified) 164
No Information 134
Use of Device Issue 42
Contamination during use 33
No code available 25
Device expiration issue 20
Leak 19
Device operates differently than expected 18
Material discolored 15
Device handling issue 15
Sterility 13
Improper or incorrect procedure or method 13
Bacterial contamination of device 8
Device emits odor 8
Tap water, use of 5
Break 5
Foreign material present in device 5
Foreign material 4
Incomplete or missing packaging 4
Device or device component damaged by another device 4
Device markings issue 4
Disposable 3
Defective item 3
Crack 3
Unexpected therapeutic results 3
Burst 2
Failure to obtain samples 2
Residue after decontamination 2
Tear, rip or hole in device packaging 1
Labeling, missing 1
Device abrasion from instrument or another object 1
Normal 1
Difficult to open or close 1
Patient-device incompatibility 1
Chemical issue 1
Degraded 1
Instruction for use issue 1
Disinfection, inadequate/improper 1
Lens, toric 1
Reaction 1
Difficult to remove 1
Short fill 1
Inadequate instructions for non-healthcare professional 1
Naturally worn 1
Total Device Problems 1447

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc (AMO) II Nov-02-2010
2 Advanced Medical Optics, Inc. I Jul-19-2007
3 Advanced Medical Optics, Inc. II Mar-01-2007
4 Bausch & Lomb Inc II Nov-10-2009
5 Bausch & Lomb Inc II Aug-13-2009
6 Marietta Vision III Mar-04-2011

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