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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
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 6 6
Material Separation 5 5
Insufficient Information 3 3
Material Fragmentation 3 3
Improper or Incorrect Procedure or Method 3 3
Mechanical Problem 2 3
Unintended System Motion 1 1
Fracture 1 1
Fitting Problem 1 1
Material Twisted/Bent 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 6 6
Intraocular Pressure, Delayed, Uncontrolled 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Zonular Dehiscence 4 4
Insufficient Information 3 3
Eye Injury 2 3
Hematoma 1 1
Loss of Vision 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Consequences Or Impact To Patient 1 1

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