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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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Break 22 22
Material Twisted/Bent 11 11
Suction Failure 7 7
Scratched Material 6 6
Sharp Edges 5 5
Material Integrity Problem 4 4
Device Operates Differently Than Expected 4 4
Component Missing 4 4
Defective Device 4 4
Misassembled 4 4
Delivered as Unsterile Product 4 4
Suction Problem 3 3
Complete Blockage 3 3
Material Fragmentation 3 3
Structural Problem 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Material Deformation 2 2
Connection Problem 2 2
Loose or Intermittent Connection 2 2
Obstruction of Flow 2 2
Inability to Irrigate 2 2
Disconnection 2 2
Collapse 2 2
Crack 2 2
Defective Component 2 2
Material Too Rigid or Stiff 2 2
Device Slipped 2 2
Particulates 2 2
Material Puncture/Hole 1 1
Decrease in Suction 1 1
Inaccurate Flow Rate 1 1
Leak/Splash 1 1
Dull, Blunt 1 1
Detachment of Device or Device Component 1 1
Malposition of Device 1 1
Aspiration Issue 1 1
Device Unsafe to Use in Environment 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Torn Material 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Capsular Bag Tear 34 34
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
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Vitritis 4 4
Corneal Edema 4 4
Inflammation 3 3
Conjunctivitis 2 2
Eye Burn 2 2
No Code Available 2 2
Fibrosis 1 1
No Information 1 1
Excessive Tear Production 1 1
No Patient Involvement 1 1
Hypopyon 1 1
Unspecified Infection 1 1
Blurred Vision 1 1

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