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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 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 CodeOJK
Regulation Number 886.4790
Device Class 2

MDR Year MDR Reports MDR Events
2018 3 3
2019 16 16
2020 13 13
2021 4 4
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 9 9
Contamination /Decontamination Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Contamination 5 5
Material Fragmentation 5 5
Appropriate Term/Code Not Available 3 3
Particulates 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Insufficient Information 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Delivered as Unsterile Product 1 1
Device Fell 1 1
Component Falling 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
No Clinical Signs, Symptoms or Conditions 3 3
Eye Infections 2 2
Eye Injury 2 2
Foreign Body Sensation in Eye 1 1
Retinal Detachment 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Sep-08-2022
2 Avid Medical, Inc. II Mar-19-2020
3 Beaver Visitec International, Inc. II Nov-16-2021
4 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
5 ROi CPS LLC II Nov-23-2022
6 ROi CPS LLC II Nov-18-2021
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