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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
2021 4 4
2022 4 4
2023 6 6
2024 9 9
2025 14 14
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 11 11
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 4 4
Leak/Splash 2 2
Material Fragmentation 2 2
Structural Problem 2 2
Detachment of Device or Device Component 2 2
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination /Decontamination Problem 1 1
Device Difficult to Setup or Prepare 1 1
Obstruction of Flow 1 1
Failure to Cut 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Optical Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Foreign Body In Patient 10 10
Insufficient Information 5 5
Corneal Abrasion 2 2
Eye Infections 2 2
Foreign Body Sensation in Eye 1 1
Unspecified Infection 1 1
Emotional Changes 1 1
Dry Eye(s) 1 1
Needle Stick/Puncture 1 1
Depression 1 1
Eye Injury 1 1
Anxiety 1 1
Blurred Vision 1 1
Retinal Tear 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC III Nov-19-2024
2 American Contract Systems Inc. II Oct-16-2025
3 American Contract Systems, Inc. II Aug-07-2024
4 American Contract Systems, Inc. II Jan-26-2024
5 American Contract Systems, Inc. II Sep-08-2022
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 Jun-30-2025
10 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Mar-18-2025
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
19 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
24 Medline Industries, LP I Apr-07-2026
25 Medline Industries, LP II Feb-17-2026
26 Medline Industries, LP II Nov-14-2025
27 Medline Industries, LP II Nov-14-2025
28 ROi CPS LLC II Nov-23-2022
29 ROi CPS LLC II Nov-18-2021
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