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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, irrigation, ocular surgery
Regulation Description Ocular surgery irrigation device.
Product CodeKYG
Regulation Number 886.4360
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 19 19
2022 20 20
2023 23 23
2024 82 90
2025 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Adverse Event Without Identified Device or Use Problem 27 27
Sharp Edges 23 23
Material Twisted/Bent 21 21
Complete Blockage 19 19
Suction Failure 17 17
Component Missing 6 14
Decrease in Suction 6 6
Misassembled 6 14
Delivered as Unsterile Product 6 14
Obstruction of Flow 5 5
Material Fragmentation 3 3
Detachment of Device or Device Component 3 3
Suction Problem 3 3
Defective Component 2 2
Particulates 2 2
Structural Problem 2 2
Connection Problem 2 2
Loose or Intermittent Connection 2 2
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Malposition of Device 1 1
Crack 1 1
Inability to Irrigate 1 1
Material Puncture/Hole 1 1
Defective Device 1 1
Scratched Material 1 1
Material Deformation 1 1
Material Separation 1 1
Appropriate Term/Code Not Available 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 87
Capsular Bag Tear 37 37
Insufficient Information 36 36
Toxic Anterior Segment Syndrome (TASS) 12 12
Uveitis 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 5 5
Vitritis 4 4
Corneal Edema 4 4
Inflammation 3 3
Eye Burn 2 2
Conjunctivitis 2 2
Unspecified Infection 1 1
Hypopyon 1 1
Unspecified Eye / Vision Problem 1 1
Blurred Vision 1 1
Fibrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Nov-03-2023
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