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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hook, ophthalmic
Product CodeHNQ
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2016 2 2
2017 4 4
2018 15 15
2019 9 9
2020 5 5
2021 4 4
2022 5 5
2023 2 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Break 10 10
Material Separation 5 5
Insufficient Information 4 4
Material Fragmentation 4 4
Improper or Incorrect Procedure or Method 3 3
Detachment of Device or Device Component 2 2
Mechanical Problem 2 3
Unintended System Motion 1 1
Detachment Of Device Component 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Fitting Problem 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 22 22
Vitrectomy 16 16
Vitreous Loss 8 8
Foreign Body In Patient 7 7
Intraocular Pressure, Delayed, Uncontrolled 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Zonular Dehiscence 4 4
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 3 3
Eye Injury 3 4
No Code Available 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Consequences Or Impact To Patient 1 1
Hematoma 1 1
Loss of Vision 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Apr-26-2022
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