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TPLC
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Device
sponge, ophthalmic
Regulation Description
Ophthalmic sponge.
Product Code
HOZ
Regulation Number
886.4790
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
1
1
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Contamination /Decontamination Problem
2
2
Particulates
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Disintegration
1
1
Patient-Device Incompatibility
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Material Deformation
1
1
Optical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Itching Sensation
2
2
Foreign Body In Patient
2
2
Peeling
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Red Eye(s)
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Edema
1
1
Blister
1
1
Foreign Body Reaction
1
1
Rash
1
1
Burning Sensation
1
1
Discomfort
1
1
Unspecified Eye / Vision Problem
1
1
Insufficient Information
1
1
Eye Injury
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beaver Visitec International, Inc.
II
Mar-01-2023
2
Carwild Corporation
II
Jan-02-2025
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
4
Stradis Medical, LLC dba Stradis Healthcare
II
Dec-14-2022
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