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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sponge, ophthalmic
Product CodeHOZ
Regulation Number 886.4790
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 1 1
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Particulates 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Chemical Problem 1 1
Material Disintegration 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 3 3
Foreign Body In Patient 2 2
Erythema 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
Dry Eye(s) 1 1
Inflammation 1 1
Edema 1 1
Eye Burn 1 1
Blister 1 1
Foreign Body Reaction 1 1
Irritation 1 1
Rash 1 1
Burning Sensation 1 1
Swelling 1 1
Discomfort 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Pain 1 1
Eye Injury 1 1
Reaction 1 1
Swelling/ Edema 1 1
Headache 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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