Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
2016 5 5
2017 10 10
2018 8 8
2019 6 6
2020 54 54
2021 40 40
2022 40 40
2023 92 92
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 230 230
Suction Failure 36 36
Suction Problem 18 18
Device Markings/Labelling Problem 7 7
Device Operates Differently Than Expected 5 5
Break 5 5
Mechanical Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Air/Gas in Device 4 4
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 3 3
Incorrect Device Or Component Shipped 3 3
Decrease in Suction 3 3
Disconnection 2 2
Complete Blockage 2 2
Contamination 2 2
Dull, Blunt 2 2
Device Displays Incorrect Message 2 2
Output Problem 2 2
Physical Property Issue 2 2
Material Separation 2 2
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Defective Device 1 1
Mechanics Altered 1 1
Operating System Becomes Nonfunctional 1 1
Failure to Calibrate 1 1
Dent in Material 1 1
Fitting Problem 1 1
Defective Component 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
Device Reprocessing Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
No Consequences Or Impact To Patient 41 41
Insufficient Information 23 23
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 7 7
Intraocular Pressure Increased 5 5
Vitrectomy 4 4
Eye Injury 4 4
Intraocular Pressure Decreased 2 2
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vitreous Hemorrhage 2 2
Capsular Bag Tear 2 2
Device Embedded In Tissue or Plaque 2 2
Joint Contracture 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
-
-