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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluid, intraocular
Regulation Description Intraocular fluid.
Product CodeLWL
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 1 0 1 3 0

MDR Year MDR Reports MDR Events
2017 3 3
2018 6 6
2019 2 2
2020 7 7
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Appropriate Term/Code Not Available 5 5
Migration or Expulsion of Device 4 4
Patient-Device Incompatibility 4 4
Insufficient Information 2 2
Break 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Retinal Detachment 6 6
Visual Impairment 5 5
Hemorrhage/Bleeding 5 5
Foreign Body In Patient 3 3
Toxic Anterior Segment Syndrome (TASS) 2 2
Hypopyon 2 2
Inflammation 2 2
Intraocular Pressure Increased 2 2
Ischemia 2 2
Endophthalmitis 2 2
Eye Injury 1 1
Scar Tissue 1 1
Loss of Vision 1 1
Weakness 1 1
Injury 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Optical Nerve Damage 1 1
Paralysis 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

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