MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATARACT PACK

Catalog Number	DYNJ44929G
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "i identified a black discoloration on the inside of a syringe prior to usage on (b)(6) 2025.Concerned it was a contamination, we tore down all setup that had been opened." per the facility, "a patient was not involved or in the room at the time; the case was only delayed by 15-20 minutes." the product has been requested for evaluation.No additional information at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to the facility, "i identified a black discoloration on the inside of a syringe prior to usage on (b)(6) 2025.Concerned it was a contamination, we tore down all setup that had been opened." per the facility, "a patient was not involved or in the room at the time; the case was only delayed by 15-20 minutes.".

• Common Device Name: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23056936
• Report Number: 1423395-2025-00123
• Device Sequence Number: 9503745
• Product Code: OJK
• UDI-Device Identifier: 10198459050893
• UDI-Public: 10198459050893
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ44929G
• Device Lot Number: 25FDA740
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown