• 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
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Markings / Labelling Problem 7
Failure to Cut 4
Device Operates Differently Than Expected 3
Incorrect Device Or Component Shipped 3
Device Operational Issue 2
Physical Property Issue 2
Flaked 1
Total Device Problems 22

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-16-2017

-
-