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 sponge, ophthalmic
Product CodeHOZ
Regulation Number 886.4790
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 2 2
2019 1 1
2020 2 2
2021 1 1
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Particulates 2 2
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Optical Problem 1 1
Material Fragmentation 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Chemical Problem 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 3 3
Peeling 2 2
Erythema 2 2
Itching Sensation 2 2
Pain 1 1
Dry Eye(s) 1 1
Edema 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Irritation 1 1
Red Eye(s) 1 1
Swelling 1 1
Burning Sensation 1 1
Discomfort 1 1
Reaction 1 1
Eye Burn 1 1
No Information 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec International, Inc. II Mar-01-2023
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
3 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
-
-