• 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 hook, ophthalmic
Product CodeHNQ
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 5 5
2021 4 4
2022 5 5
2023 2 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Use of Device Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Improper or Incorrect Procedure or Method 3 3
Material Fragmentation 3 3
Mechanical Problem 2 3
Unintended System Motion 1 1
Fitting Problem 1 1
Material Twisted/Bent 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Bag Tear 9 9
Vitrectomy 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Zonular Dehiscence 4 4
Insufficient Information 3 3
Foreign Body In Patient 3 3
Eye Injury 2 3
Vitreous Loss 2 2
No Consequences Or Impact To Patient 1 1
Hematoma 1 1
Loss of Vision 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec AG II Apr-26-2022
-
-