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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
2016 14 14
2017 10 10
2018 10 10
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 32 32
Break 28 28
Material Twisted/Bent 16 16
Sharp Edges 10 10
Complete Blockage 9 9
Suction Failure 9 9
Component Missing 6 14
Scratched Material 6 6
Misassembled 6 14
Delivered as Unsterile Product 6 14
Material Integrity Problem 4 4
Defective Device 4 4
Device Operates Differently Than Expected 4 4
Suction Problem 3 3
Insufficient Information 3 3
Loose or Intermittent Connection 3 3
Material Fragmentation 3 3
Structural Problem 3 3
Connection Problem 2 2
Obstruction of Flow 2 2
Material Too Rigid or Stiff 2 2
Defective Component 2 2
Crack 2 2
Appropriate Term/Code Not Available 2 2
Material Deformation 2 2
Decrease in Suction 2 2
Particulates 2 2
Inability to Irrigate 2 2
Collapse 2 2
Disconnection 2 2
Device Slipped 2 2
Device Unsafe to Use in Environment 1 1
Malposition of Device 1 1
Torn Material 1 1
Infusion or Flow Problem 1 1
Inaccurate Flow Rate 1 1
Material Puncture/Hole 1 1
Noise, Audible 1 1
Dull, Blunt 1 1
Material Split, Cut or Torn 1 1
Leak/Splash 1 1
Pressure Problem 1 1
Aspiration Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 66
Capsular Bag Tear 38 38
Insufficient Information 19 19
No Known Impact Or Consequence To Patient 16 16
Toxic Anterior Segment Syndrome (TASS) 12 12
Uveitis 10 10
Rupture 9 9
No Consequences Or Impact To Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Vitritis 4 4
Corneal Edema 4 4
Inflammation 3 3
No Code Available 2 2
Eye Burn 2 2
Conjunctivitis 2 2
Unspecified Infection 1 1
Hypopyon 1 1
No Information 1 1
No Patient Involvement 1 1
Blurred Vision 1 1
Fibrosis 1 1
Excessive Tear Production 1 1

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