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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
2020 13 13
2021 4 4
2022 4 4
2023 6 6
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 12 12
Contamination 9 9
Connection Problem 5 5
Leak/Splash 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Integrity Problem 4 4
Contamination /Decontamination Problem 3 3
Material Fragmentation 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Material Split, Cut or Torn 2 2
Failure to Seal 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Foreign Body In Patient 9 9
Unspecified Infection 4 4
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 3 3
Toxic Anterior Segment Syndrome (TASS) 3 3
Eye Injury 2 2
Eye Infections 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body Sensation in Eye 1 1
Needle Stick/Puncture 1 1
Retinal Detachment 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC III Nov-19-2024
2 American Contract Systems, Inc. II Aug-07-2024
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 Avid Medical, Inc. II Mar-19-2020
6 Beaver Visitec International, Inc. II Nov-16-2021
7 Cardinal Health 200, LLC II Feb-10-2025
8 Cardinal Health 200, LLC II Jan-15-2025
9 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
14 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
16 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
19 ROi CPS LLC II Nov-23-2022
20 ROi CPS LLC II Nov-18-2021
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