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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, patient, ophthalmic
Product CodeHMT
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2014 2 2
2017 2 2
2020 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Degraded 1 1
Entrapment of Device 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Peeling 2 2
No Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Corneal Abrasion 1 1
Erythema 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II Sep-24-2014
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