• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device vitrectomy, instrument cutter
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISTA OPHTHALMICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 10 10
2018 8 8
2019 6 6
2020 54 54
2021 40 40
2022 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 97 97
Suction Problem 7 7
Device Markings/Labelling Problem 7 7
Device Operates Differently Than Expected 5 5
Incorrect Device Or Component Shipped 3 3
Therapeutic or Diagnostic Output Failure 3 3
Break 3 3
Dull, Blunt 2 2
Physical Property Issue 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Gas Leak 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Air/Gas in Device 1 1
Failure to Calibrate 1 1
Dent in Material 1 1
Defective Component 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Reprocessing Problem 1 1
Decrease in Suction 1 1
Entrapment of Device 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
No Device Output 1 1
Failure to Power Up 1 1
Failure to Prime 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66 66
No Consequences Or Impact To Patient 41 41
No Known Impact Or Consequence To Patient 16 16
No Patient Involvement 7 7
Insufficient Information 3 3
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Capsular Bag Tear 2 2
Eye Injury 1 1
Intraocular Pressure Increased 1 1
Retinal Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-16-2017
2 Johnson & Johnson Surgical Vision Inc II Jun-28-2019
-
-