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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
2020 8 8
2021 19 19
2022 20 20
2023 23 23
2024 83 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Break 27 27
Sharp Edges 22 22
Complete Blockage 18 18
Material Twisted/Bent 17 17
Suction Failure 10 10
Component Missing 6 14
Misassembled 6 14
Delivered as Unsterile Product 6 14
Material Fragmentation 3 3
Obstruction of Flow 3 3
Decrease in Suction 3 3
Suction Problem 3 3
Defective Component 2 2
Particulates 2 2
Structural Problem 2 2
Detachment of Device or Device Component 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
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 77
Capsular Bag Tear 37 37
Insufficient Information 29 29
Toxic Anterior Segment Syndrome (TASS) 12 12
Uveitis 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 5 5
Corneal Edema 5 5
Inflammation 4 4
Vitritis 4 4
Unspecified Infection 2 2
Eye Burn 2 2
Conjunctivitis 2 2
Hypersensitivity/Allergic reaction 1 1
Hypopyon 1 1
Endophthalmitis 1 1
Eye Injury 1 1
Blurred Vision 1 1
Intraocular Pressure Decreased 1 1
Fibrosis 1 1

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