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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device case, contact lens
Product CodeLRX
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DANYANG CHANXIN GLASSES CASES FACTORY
  SUBSTANTIALLY EQUIVALENT 1
E-LINK PLASTIC & METAL INDUSTRIAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
FIFTYTWOWAYS LTD
  SUBSTANTIALLY EQUIVALENT 1
MACA PLASTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NI HAU INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO LISHUNDA ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YINZHOU ZONGHAI ARTWARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVABAY PHARMACEUTICALS, INC
  SUBSTANTIALLY EQUIVALENT 1
P L OVERSEAS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIOPTI LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Instructions for Non-Healthcare Professional 1 1
Use of Device Problem 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 1 1
No Information 1 1
Neovascularization 1 1
Chemical Exposure 1 1
Burning Sensation 1 1
Swelling 1 1
Insufficient Information 1 1

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