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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device eye tray
Regulation Description Ophthalmic sponge.
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 CodeOJK
Regulation Number 886.4790
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 3 3
2019 16 16
2020 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 10 10
Contamination /Decontamination Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Fragmentation 4 4
Particulates 2 2
Device Dislodged or Dislocated 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Device Fell 1 1
Component Falling 1 1
Contamination 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 13 13
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 3 3
Unspecified Infection 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Eye Injury 2 2
Retinal Detachment 1 1
Visual Impairment 1 1
Device Embedded In Tissue or Plaque 1 1
Retinal Tear 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 Customed, Inc II Apr-14-2016
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