• 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 knife, ophthalmic
Product CodeHNN
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2019 291 291
2020 493 493
2021 403 403
2022 327 449
2023 352 352
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Dull, Blunt 1047 1047
Fail-Safe Did Not Operate 410 410
Failure to Cut 130 130
Particulates 51 51
Adverse Event Without Identified Device or Use Problem 47 169
Material Twisted/Bent 45 45
Fail-Safe Problem 45 45
Protective Measures Problem 42 42
Material Fragmentation 41 41
Insufficient Information 16 16
Appropriate Term/Code Not Available 13 13
Defective Device 8 8
Tear, Rip or Hole in Device Packaging 7 7
Flaked 6 6
Sharp Edges 5 5
Packaging Problem 5 5
Break 4 4
Degraded 4 4
Material Disintegration 4 4
Material Protrusion/Extrusion 4 4
Material Deformation 4 4
Material Integrity Problem 3 3
Mechanics Altered 3 3
Device Contamination with Chemical or Other Material 3 3
Contamination /Decontamination Problem 3 3
Material Too Rigid or Stiff 3 3
Failure to Advance 3 3
Fitting Problem 3 3
Defective Component 3 3
Component Missing 2 2
Use of Device Problem 2 2
Inadequacy of Device Shape and/or Size 1 1
Contamination 1 1
Mechanical Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Detachment of Device or Device Component 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1063 1063
No Patient Involvement 276 276
No Known Impact Or Consequence To Patient 205 205
No Consequences Or Impact To Patient 158 158
Insufficient Information 45 45
Foreign Body In Patient 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Laceration(s) 28 28
Device Embedded In Tissue or Plaque 16 16
Inflammation 11 11
Corneal Edema 10 10
Endophthalmitis 10 10
Eye Injury 8 8
Corneal Perforation 8 8
Capsular Bag Tear 8 8
Toxic Anterior Segment Syndrome (TASS) 8 8
Vitritis 7 7
Uveitis 7 7
Needle Stick/Puncture 5 5
Prolapse 4 4
No Code Available 3 3
Intraocular Pressure Decreased 3 3
Conjunctivitis 3 3
Corneal Abrasion 2 2
Visual Impairment 2 2
Fibrosis 2 2
Hypopyon 2 2
Complaint, Ill-Defined 1 1
Injury 1 1
Fluid Discharge 1 1
Visual Disturbances 1 1
Blurred Vision 1 1
Irritation 1 1
Itching Sensation 1 123
Tissue Damage 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 123
Corneal Scar 1 1
Foreign Body Sensation in Eye 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc Irb II Aug-24-2019
2 Beaver Visitec II Apr-09-2019
3 Beaver Visitec III Apr-04-2019
4 Beaver Visitec International, Inc. II Jan-04-2024
5 Beaver Visitec International, Inc. II Jan-04-2024
6 Beaver Visitec International, Inc. II Jan-04-2023
7 Beaver Visitec International, Inc. II Nov-16-2021
8 International Science & Technology, LP, DBA Diamatrix Ltd. II May-20-2022
-
-