• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 17
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 12
ALTAIRE PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 17
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 428
Other (for use when an appropriate device code cannot be identified) 164
No Information 134
Product quality issue 48
Use of Device Issue 43
Contamination during use 33
Device operates differently than expected 28
No code available 25
Device expiration issue 21
Leak 19
Material discolored 15
Device handling issue 15
Improper or incorrect procedure or method 13
Sterility 13
Bacterial contamination of device 8
Device emits odor 8
Device markings issue 6
Foreign material present in device 5
Break 5
Tap water, use of 5
Incomplete or missing packaging 4
Device or device component damaged by another device 4
Foreign material 4
Crack 3
Disposable 3
Defective item 3
Unexpected therapeutic results 3
Residue after decontamination 2
Failure to obtain samples 2
Burst 2
Degraded 1
Instruction for use issue 1
Disinfection, inadequate/improper 1
Device abrasion from instrument or another object 1
Normal 1
Reaction 1
Difficult to remove 1
Short fill 1
Patient-device incompatibility 1
Chemical issue 1
Difficult to open or close 1
Tear, rip or hole in device packaging 1
Labeling, missing 1
Lens, toric 1
Inadequate instructions for non-healthcare professional 1
Naturally worn 1
Not Applicable 1
Total Device Problems 1528

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 1
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 Bausch & Lomb Inc Irb II Nov-21-2016
7 Marietta Vision III Mar-04-2011

-
-