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

Catalog Number	DYNJ38874C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Eye Injury (1845); Retinal Tear (2050)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 the cannula detached from the syringe and was "injected into the eye".Per the facility this caused "a retinal tear x 2 requiring laser by retina team and follow up with them, also caused an unplanned posterior capsular tear requiring anterior vitrectomy".A sample of the product was requested for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2025 the cannula detached from the syringe and was "injected into the eye".

• Common Device Name: DBD-CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22930999
• Report Number: 1423395-2025-00099
• Device Sequence Number: 10223382
• Product Code: OJK
• UDI-Device Identifier: 10195327593926
• UDI-Public: 10195327593926
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ38874C
• Device Lot Number: 24JME352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 43 KG