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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 14
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 3
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 3
EYEYON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GELFLEX LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON VISION CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
JOOWON INNOVATION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LARGAN MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
PEGAVISION CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
POLYDEV LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED SRL
  SUBSTANTIALLY EQUIVALENT 1
ST. SHINE OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISCO TECHNOLOGY SDN. BHD
  SUBSTANTIALLY EQUIVALENT 3
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 3
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Contact Lens 306
No Apparent Adverse Event 196
Adverse Event Without Identified Device or Use Problem 167
Insufficient Information 31
Device Operates Differently Than Expected 8
Patient-Device Incompatibility 4
Appropriate Term/Code Not Available 3
Component Missing 2
Improper or Incorrect Procedure or Method 2
Naturally Worn 2
Torn Material 2
Break 2
Product Quality Problem 1
Use of Device Problem 1
Material Integrity Problem 1
Expulsion 1
Sticking 1
Defective Device 1
Packaging Problem 1
Difficult to Remove 1
Total Device Problems 733

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 Johnson & Johnson Vision Care, Inc. II Apr-11-2019
5 Johnson & Johnson Vision Care, Inc. II Aug-23-2018
6 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
7 The See Clear Company II Mar-03-2017

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