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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
ACUITY POLYMERS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ART OPTICAL CONTACT LENS INC
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH + LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BOSTONSIGHT
  SUBSTANTIALLY EQUIVALENT 1
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 5
E&E OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
VALLEY CONTAX, INC.
  SUBSTANTIALLY EQUIVALENT 3
VISIONARY OPTICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2019 5 5
2020 2 2
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Use of Device Problem 1 1
Break 1 1
Labelling, Instructions for Use or Training Problem 1 1

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

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