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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
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 10 10
Adverse Event Without Identified Device or Use Problem 6 6
Contamination /Decontamination Problem 6 6
Contamination 4 4
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
Delivered as Unsterile Product 1 1
Component Falling 1 1
Device Fell 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
Unspecified Infection 4 4
No Consequences Or Impact To Patient 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Eye Infections 2 2
Eye Injury 2 2
Device Embedded In Tissue or Plaque 1 1
Retinal Detachment 1 1
Retinal Tear 1 1
Visual Impairment 1 1
No Clinical Signs, Symptoms or Conditions 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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