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TPLC
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show TPLC since
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Device
sponge, ophthalmic
Product Code
HOZ
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
Patient-Device Incompatibility
2
2
Contamination /Decontamination Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Particulates
2
2
Chemical Problem
1
1
Difficult to Remove
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Optical Problem
1
1
Material Deformation
1
1
Material Fragmentation
1
1
Manufacturing, Packaging or Shipping Problem
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
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