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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Device Problem Term/Code Not Available 8 8
Material Integrity Problem 8 8
Contamination 6 6
Leak/Splash 4 4
Material Frayed 4 4
Structural Problem 4 4
Insufficient Device Problem Information 1 1
Connection Problem 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Device Markings/Labelling Problem 1 1
Contamination /Decontamination Problem 1 1
Material Deformation 1 1
Material Split, Cut or Torn 1 1
Fluid/Blood Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 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 14 14
Insufficient Information 5 5
Corneal Abrasion 5 5
Eye Infections 2 2
Anxiety 1 1
Blurred Vision 1 1
Emotional Changes 1 1
Photophobia 1 1
Eye Injury 1 1
Retinal Tear 1 1
Unspecified Infection 1 1
Foreign Body Sensation in Eye 1 1
Needle Stick/Puncture 1 1
Dry Eye(s) 1 1
Depression 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 II Jun-29-2026
25 Medline Industries, LP II Jun-17-2026
26 Medline Industries, LP II Jun-12-2026
27 Medline Industries, LP II May-28-2026
28 Medline Industries, LP II May-07-2026
29 Medline Industries, LP II Apr-30-2026
30 Medline Industries, LP II Apr-17-2026
31 Medline Industries, LP I Apr-07-2026
32 Medline Industries, LP II Feb-17-2026
33 Medline Industries, LP II Nov-14-2025
34 Medline Industries, LP II Nov-14-2025
35 ROi CPS LLC II Nov-23-2022
36 ROi CPS LLC II Nov-18-2021
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