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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 9 9
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 12 12
Appropriate Term/Code Not Available 10 10
Material Integrity Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Contamination /Decontamination Problem 3 3
Leak/Splash 2 2
Material Fragmentation 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 2 2
Device Dislodged or Dislocated 2 2
Material Split, Cut or Torn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Particulates 1 1
Failure to Cut 1 1
Material Deformation 1 1
Optical Problem 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 17 17
Foreign Body In Patient 10 10
Insufficient Information 5 5
Unspecified Infection 4 4
Toxic Anterior Segment Syndrome (TASS) 3 3
No Known Impact Or Consequence To Patient 3 3
Eye Injury 3 3
Eye Infections 2 2
Foreign Body Sensation in Eye 1 1
Emotional Changes 1 1
Dry Eye(s) 1 1
Needle Stick/Puncture 1 1
Retinal Detachment 1 1
Depression 1 1
Anxiety 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 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 Avid Medical, Inc. II Mar-19-2020
7 Beaver Visitec International, Inc. II Nov-16-2021
8 Cardinal Health 200, LLC II Feb-10-2025
9 Cardinal Health 200, LLC II Jan-15-2025
10 MEDLINE INDUSTRIES, LP - Northfield II Jun-30-2025
11 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
14 MEDLINE INDUSTRIES, LP - Northfield II Mar-18-2025
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
20 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
22 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
25 ROi CPS LLC II Nov-23-2022
26 ROi CPS LLC II Nov-18-2021
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