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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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 10 10
Contamination 9 9
Device Contamination with Chemical or Other Material 8 8
Contamination /Decontamination Problem 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
Insufficient Information 1 1
Particulates 1 1
Delivered as Unsterile Product 1 1
Detachment of Device or Device Component 1 1
Failure to Seal 1 1
Device Difficult to Setup or Prepare 1 1
Component Missing 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
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
Insufficient Information 2 2
Eye Injury 2 2
Eye Infections 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body Sensation in Eye 1 1
Needle Stick/Puncture 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 Aug-07-2024
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 Avid Medical, Inc. II Mar-19-2020
5 Beaver Visitec International, Inc. II Nov-16-2021
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
14 ROi CPS LLC II Nov-23-2022
15 ROi CPS LLC II Nov-18-2021
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