MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; EYE MUSCLE

Catalog Number	DYNJ54723A
Medical Device Problem Codes	Material Frayed (1262); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2026, the "qtips (listed in the pack as cotton tip applicator were used from pack) - noted to have fraying fibers on some of the applicators.Some were worse than others, but fibers were coming off of the applicator when used in the surgical site (eye) and requiring the surgeon to pull these from the surgical site.No harm occurred.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, the "qtips (listed in the pack as cotton tip applicator were used from pack) - noted to have fraying fibers on some of the applicators.Some were worse than others, but fibers were coming off of the applicator when used in the surgical site (eye) and requiring the surgeon to pull these from the surgical site.No harm occurred.It has been determined that the reported event could cause or contribute 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.

• Brand Name: MEDLINE
• Common Device Name: EYE MUSCLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24941577
• Report Number: 1423395-2026-00103
• Device Sequence Number: 12993414
• Product Code: OJK
• UDI-Device Identifier: 10195327020415
• UDI-Public: 10195327020415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ54723A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 24 MO
• Patient Sex: Male