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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical eye tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePZG
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec International, Inc. II Dec-21-2021
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