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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
2019 16 16
2020 13 13
2021 4 4
2022 4 4
2023 6 6
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 9 9
Device Contamination with Chemical or Other Material 8 8
Contamination /Decontamination Problem 7 7
Appropriate Term/Code Not Available 7 7
Material Fragmentation 6 6
Leak/Splash 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Connection Problem 5 5
Material Integrity Problem 4 4
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Failure to Seal 1 1
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Delivered as Unsterile Product 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Foreign Body In Patient 18 18
No Known Impact Or Consequence To Patient 8 8
Unspecified Infection 4 4
Toxic Anterior Segment Syndrome (TASS) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Eye Infections 2 2
Eye Injury 2 2
No Consequences Or Impact To Patient 2 2
Needle Stick/Puncture 1 1
Device Embedded In Tissue or Plaque 1 1
Foreign Body Sensation in Eye 1 1
Retinal Detachment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Sep-08-2022
3 Avid Medical, Inc. II Mar-19-2020
4 Beaver Visitec International, Inc. II Nov-16-2021
5 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
10 ROi CPS LLC II Nov-23-2022
11 ROi CPS LLC II Nov-18-2021
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