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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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Adverse Event Without Identified Device or Use Problem 11 11
Material Fragmentation 9 9
Material Too Rigid or Stiff 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Fitting Problem 2 2
Difficult to Open or Close 2 2
Loose or Intermittent Connection 2 2
Device Fell 1 1
Defective Component 1 1
Key or Button Unresponsive/not Working 1 1
Material Deformation 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 35 35
Inflammation 7 7
Eye Injury 7 7
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 4 4
Intraocular Pressure Decreased 4 4
Insufficient Information 3 3
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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