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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, contact (other material) - daily
Regulation Description Rigid gas permeable contact lens.
Product CodeHQD
Regulation Number 886.5916
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED VISION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BOSTON FOUNDATION FOR SIGHT
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 5
COOPERVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEYES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 5 5
2016 1 1
2017 3 3
2019 5 5
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Break 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 6 6
Keratitis 3 3
Pain 2 2
Unspecified Infection 2 2
Discomfort 2 2
Conjunctivitis 2 2
Corneal Abrasion 2 2
Corneal Edema 2 2
Toxicity 1 1
Abrasion 1 1
Red Eye(s) 1 1
Visual Impairment 1 1
Acanthameba Keratitis 1 1
Hyphema 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alden Optical III Sep-06-2018
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