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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatula, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHND
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 5 5
2023 13 13
2024 9 9
2025 23 23
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Adverse Event Without Identified Device or Use Problem 11 11
Material Fragmentation 10 10
Material Too Rigid or Stiff 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Fitting Problem 2 2
Material Deformation 2 2
Difficult to Open or Close 2 2
Loose or Intermittent Connection 2 2
Activation Problem 1 1
Device Fell 1 1
Defective Component 1 1
Key or Button Unresponsive/not Working 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Inflammation 7 7
Eye Injury 7 7
Insufficient Information 6 6
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 4 4
Intraocular Pressure Decreased 4 4
Eye Infections 3 3
Foreign Body In Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Visual Disturbances 1 1
Discomfort 1 1
Vitreous Hemorrhage 1 1

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