• 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 Show TPLC since Back To Search Results
Device lenses, soft contact, daily wear
Regulation Description Soft (hydrophilic) contact lens.
Product CodeLPL
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 14
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 14
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 3
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 3
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 4
EYEYON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FIRESTONE OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GELFLEX LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
JOOWON INNOVATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LARGAN MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEO VISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
POLYDEV LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 2
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEINOH OPTICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUFLON PHARMACEUTICALS LTD
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNICON OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNILENS CORP., USA
  SUBSTANTIALLY EQUIVALENT 1
VALEANT PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
VASSEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO TECHNOLOGY SDN. BHD
  SUBSTANTIALLY EQUIVALENT 2
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 2
VISION SCIENCE CO LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Contact Lens 377
No Apparent Adverse Event 196
Adverse Event Without Identified Device or Use Problem 159
Insufficient Information 31
Device Operates Differently Than Expected 8
Torn Material 6
Patient-Device Incompatibility 5
Appropriate Term/Code Not Available 4
Improper or Incorrect Procedure or Method 3
Disposable 2
Use of Device Problem 2
Component Missing 2
Break 2
Naturally Worn 2
Packaging Problem 1
Defective Device 1
Material Rupture 1
Sticking 1
Expulsion 1
Material Integrity Problem 1
Product Quality Problem 1
Difficult to Remove 1
Total Device Problems 807

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical II Mar-13-2018
2 Bausch & Lomb Inc Irb II Nov-04-2015
3 Ciba Vision Corporation II Jun-25-2015
4 Cooper Vision Caribbean Corp. III Oct-24-2014
5 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
6 Johnson & Johnson Vision Care, Inc. II Aug-23-2018
7 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
8 The See Clear Company II Mar-03-2017

-
-