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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, surgical, general & plastic surgery
Product CodeFSO
Regulation Number 878.4700
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 7 7
2021 19 19
2022 5 5
2023 17 17
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 15 15
Unstable 7 7
Optical Problem 7 7
Device Dislodged or Dislocated 6 6
Installation-Related Problem 6 6
Detachment of Device or Device Component 6 6
Use of Device Problem 6 6
Unexpected Shutdown 3 3
Physical Resistance/Sticking 3 3
Noise, Audible 2 2
Computer Software Problem 2 2
No Apparent Adverse Event 2 2
Device Handling Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misassembly During Maintenance/Repair 2 2
Component Missing 2 2
Positioning Problem 2 2
Poor Quality Image 2 2
Mechanical Problem 2 2
Break 2 2
Patient Device Interaction Problem 1 1
Key or Button Unresponsive/not Working 1 1
Unraveled Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Integrity Problem 1 1
Failure to Align 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Vibration 1 1
Insufficient Information 1 1
Calibration Problem 1 1
Energy Output Problem 1 1
Unintended Electrical Shock 1 1
Product Quality Problem 1 1
Communication or Transmission Problem 1 1
Failure to Calibrate 1 1
Reset Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Connection Problem 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Misfocusing 1 1
Operating System Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Patient Involvement 6 6
Insufficient Information 6 6
Eye Burn 5 5
No Known Impact Or Consequence To Patient 4 4
Eye Injury 3 3
Bruise/Contusion 3 3
Perforation of Vessels 2 2
No Consequences Or Impact To Patient 2 2
Superficial (First Degree) Burn 1 1
Stroke/CVA 1 1
Electric Shock 1 1
No Code Available 1 1
No Information 1 1
Abrasion 1 1
Burn, Thermal 1 1
Capsular Bag Tear 1 1
Laceration(s) 1 1
Swelling/ Edema 1 1
Tinnitus 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Aug-11-2022
2 Aesculap Implant Systems LLC II Jul-19-2022
3 Aesculap Inc II Jun-12-2024
4 Carl Zeiss Suzhou Co., Ltd. II Oct-26-2023
5 Leica Microsystems, Inc. II Sep-29-2022
6 Leica Microsystems, Inc. II Dec-22-2021
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