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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
2019 23 23
2020 27 27
2021 24 24
2022 17 17
2023 23 23
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 65 65
Unintended Movement 11 11
Appropriate Term/Code Not Available 7 7
Optical Problem 6 6
Break 5 5
Misfocusing 4 4
Unstable 4 4
Defective Component 4 4
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 3 3
Device Slipped 3 3
Device Fell 2 2
Installation-Related Problem 2 2
Optical Obstruction 2 2
Use of Device Problem 2 2
Unintended System Motion 2 2
Failure to Align 2 2
Defective Device 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Particulates 1 1
Material Too Rigid or Stiff 1 1
Poor Quality Image 1 1
Mechanical Problem 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
No Display/Image 1 1
Image Display Error/Artifact 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
No Known Impact Or Consequence To Patient 25 25
Capsular Bag Tear 10 10
No Consequences Or Impact To Patient 7 7
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Patient Involvement 3 3
Eye Injury 3 3
Rupture 2 2
Inflammation 2 2
Intraocular Pressure Increased 2 2
Laceration(s) 2 2
Retinal Injury 1 1
Discomfort 1 1
Vitreous Detachment 1 1
Hemorrhage/Bleeding 1 1
Unspecified Eye / Vision Problem 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research Laboratories Ltd. II Feb-27-2019
2 Haag-Streit USA Inc II Dec-23-2020
3 Leica Microsystems, Inc. II Dec-09-2022
4 Leica Microsystems, Inc. II Feb-15-2019
5 Leica Microsystems, Inc. II Jan-24-2019
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