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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 10
  1.  K162005  Acuity 100 (hexafocon A) Rigid Gas Permeable Conta ...
  2.  K163254  Acuity 18 (enflufocon A) Rigid Gas Permeable Conta ...
  3.  K170001  Acuity 85 (Oprifocon A) Rigid Gas Permeable Contac ...
  4.  K170007  Acuity 58 (Enflufocon B) Rigid Gas Permeable Conta ...
  5.  K180988  Acuity 18 (enflufocon A) Rigid Gas Permeable Conta ...
  6.  K201194  Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable ...
  7.  K203571  Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable C ...
  8.  K213538  Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon ...
  9.  K230965  Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG ...
  10.  K240618  Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable ...
ADVANCED VISION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ART OPTICAL CONTACT LENS INC
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH & LOMB, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BAUSCH + LOMB INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
BOSTON FOUNDATION FOR SIGHT
  SUBSTANTIALLY EQUIVALENT 1
BOSTONSIGHT
  SUBSTANTIALLY EQUIVALENT 2
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 6
E&E OPTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
PARAGON VISION SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEYES, INC.
  SUBSTANTIALLY EQUIVALENT 3
VALLEY CONTAX, INC.
  SUBSTANTIALLY EQUIVALENT 3
VISIONARY OPTICS LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 26 26
2015 5 5
2016 1 1
2017 3 3
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 28 28
Appropriate Term/Code Not Available 12 12
Insufficient Information 5 5
Off-Label Use 4 4
Product Quality Problem 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Difficult to Remove 1 1
Break 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Abrasion 16 16
Corneal Ulcer 15 15
Keratitis 6 6
Conjunctivitis 5 5
Corneal Edema 4 4
Red Eye(s) 3 3
Corneal Infiltrates 3 3
Discomfort 2 2
Pain 2 2
No Code Available 2 2
Acanthameba Keratitis 2 2
Unspecified Infection 2 2
Intraocular Infection 2 2
Iritis 2 2
Neovascularization 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Halo 1 1
Corneal Scar 1 1
Corneal Pannus 1 1
Abrasion 1 1
Macular Edema 1 1
Eye Injury 1 1
Hyphema 1 1
Hypoxia 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Toxicity 1 1
Injury 1 1
No Information 1 1

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