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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, operating & accessories, ac-powered, ophthalmic
Product CodeHRM
Regulation Number 878.4700
Device Class 1

MDR Year MDR Reports MDR Events
2017 29 29
2018 30 30
2019 23 23
2020 27 27
2021 24 24
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 73 73
Unintended Movement 9 9
Device Operates Differently Than Expected 8 8
Optical Problem 7 7
Device Slipped 6 6
Unstable 5 5
Break 4 4
Misfocusing 4 4
Device Dislodged or Dislocated 4 4
Detachment of Device or Device Component 3 3
Component Falling 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Operational Issue 3 3
Installation-Related Problem 2 2
Detachment Of Device Component 2 2
Unintended System Motion 2 2
Appropriate Term/Code Not Available 2 2
Use of Device Problem 2 2
Failure to Align 2 2
Defective Device 1 1
Device Tipped Over 1 1
Component Missing 1 1
Unintended Arm Motion 1 1
No Display/Image 1 1
Mechanical Problem 1 1
Torn Material 1 1
Insufficient Information 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Mechanics Altered 1 1
Computer Software Problem 1 1
Disconnection 1 1
Sticking 1 1
Defective Component 1 1
Material Twisted/Bent 1 1
Device Handling Problem 1 1
Bent 1 1
Failure to Power Up 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 64 64
No Clinical Signs, Symptoms or Conditions 30 30
No Consequences Or Impact To Patient 14 14
Capsular Bag Tear 9 9
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Eye Injury 4 4
No Information 3 3
Inflammation 2 2
Intraocular Pressure Increased 2 2
Laceration(s) 2 2
Rupture 2 2
Injury 2 2
Vitreous Detachment 1 1
Skin Tears 1 1
Electric Shock 1 1
Discomfort 1 1
Vitrectomy 1 1
Retinal Injury 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Corneal Edema 1 1
Edema 1 1
No Code Available 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research Laboratories Ltd. II Feb-27-2019
2 Alcon Research, Ltd. II Aug-28-2017
3 Haag-Streit USA Inc II Dec-23-2020
4 Leica Microsystems, Inc. II Feb-15-2019
5 Leica Microsystems, Inc. II Jan-24-2019
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