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 laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Product CodeLXS
Regulation Number 886.4392
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 18 18
2017 3 3
2018 6 6
2019 4 4
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Therapeutic Results 19 19
Device Operates Differently Than Expected 11 11
Energy Output Problem 6 6
Misfocusing 5 5
Nonstandard Device 5 5
Energy Output To Patient Tissue Incorrect 2 2
Material Integrity Problem 2 2
Mechanics Altered 2 2
Optical Problem 2 2
Output Problem 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 1 1
Firing Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Grounding Malfunction 1 1
Electrical /Electronic Property Problem 1 1
Intermittent Shock/Stimulation 1 1
Failure to Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 6 6
No Code Available 3 3
No Information 2 2
Vitreous Floaters 1 1
Retinal Injury 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nidek Inc II Apr-02-2015
-
-