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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
Product CodeKYG
Regulation Number 886.4360
Device Class 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 8 8
2021 19 19
2022 20 20
2023 23 23
2024 48 56

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Break 24 24
Material Twisted/Bent 16 16
Sharp Edges 10 10
Suction Failure 9 9
Complete Blockage 9 9
Component Missing 6 14
Delivered as Unsterile Product 6 14
Misassembled 6 14
Structural Problem 3 3
Suction Problem 3 3
Scratched Material 3 3
Material Fragmentation 3 3
Obstruction of Flow 2 2
Particulates 2 2
Decrease in Suction 2 2
Defective Component 2 2
Connection Problem 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Material Deformation 1 1
Malposition of Device 1 1
Crack 1 1
Material Puncture/Hole 1 1
Inability to Irrigate 1 1
Defective Device 1 1
Dull, Blunt 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 66
Capsular Bag Tear 28 28
Insufficient Information 19 19
Toxic Anterior Segment Syndrome (TASS) 12 12
Uveitis 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 6 6
No Known Impact Or Consequence To Patient 5 5
Vitritis 4 4
Corneal Edema 4 4
Inflammation 3 3
Eye Burn 2 2
Conjunctivitis 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 1 1
No Code Available 1 1
Hypopyon 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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