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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 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 41 41
Adverse Event Without Identified Device or Use Problem 29 29
Suction Failure 28 28
Material Twisted/Bent 26 26
Sharp Edges 24 24
Complete Blockage 20 20
Obstruction of Flow 9 9
Component Missing 6 14
Decrease in Suction 6 6
Misassembled 6 14
Delivered as Unsterile Product 6 14
Detachment of Device or Device Component 5 5
Suction Problem 4 4
Defective Component 3 3
Material Fragmentation 3 3
Fitting Problem 2 2
Insufficient Information 2 2
Particulates 2 2
Structural Problem 2 2
Material Protrusion/Extrusion 2 2
Appropriate Term/Code Not Available 2 2
Connection Problem 2 2
Loose or Intermittent Connection 2 2
Dull, Blunt 2 2
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Malposition of Device 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Inability to Irrigate 1 1
Material Puncture/Hole 1 1
Defective Device 1 1
Scratched Material 1 1
Intermittent Infusion 1 1
Material Deformation 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 108
Insufficient Information 50 50
Capsular Bag Tear 40 40
Toxic Anterior Segment Syndrome (TASS) 14 14
Uveitis 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Rupture 7 7
Corneal Edema 6 6
Inflammation 4 4
Conjunctivitis 4 4
Vitritis 4 4
Intraocular Pressure Increased 3 3
Blurred Vision 3 3
Red Eye(s) 2 2
Eye Burn 2 2
Unspecified Eye / Vision Problem 2 2
Eye Pain 2 2
Unspecified Infection 1 1
Hypopyon 1 1
Endophthalmitis 1 1
Fibrosis 1 1

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