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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
Product CodeHQD
Regulation Number 886.5916
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCULENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUITY POLYMERS, INC.
  SUBSTANTIALLY EQUIVALENT 5
BAUSCH & LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BOSTONSIGHT
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALLEY CONTAX, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISIONARY OPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 2 2
2021 3 3
2022 3 3
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Off-Label Use 4 4
Product Quality Problem 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Conjunctivitis 5 5
Keratitis 5 5
Corneal Abrasion 4 4
Corneal Ulcer 4 4
Corneal Edema 3 3
Acanthameba Keratitis 2 2
Pain 2 2
Discomfort 2 2
Toxicity 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Corneal Pannus 1 1
Abrasion 1 1
Red Eye(s) 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Halo 1 1
Corneal Infiltrates 1 1
Corneal Scar 1 1
Hyphema 1 1
Hypoxia 1 1
Iritis 1 1

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