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
Additional Manufacturer Narrative
According to the facility on 3/23/2026, 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.Per the facility, no known harm occurred but potential for harm if the surgeon doesn't notice the fibers and does not remove from the eye/other surgical site.No follow-up care was necessary per the doctor.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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 3/23/2026, 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.

• Brand Name: MEDLINE
• Common Device Name: EYE MUSCLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24940251
• Report Number: 1423395-2026-00102
• Device Sequence Number: 15689936
• 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: 4 YR
• Patient Sex: Female