MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; EYE PACK W-BLADES

Catalog Number	DYNJ86904
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, doctors are finding white fibers in the eye while using the packs after implanting the lens.
Additional Manufacturer Narrative
According to the facility, doctors are finding white fibers in the eye while using the packs after implanting the lens.The doctors removed the fibers from the eye with an ia handpiece after implanting the lens.The facility stated there was no serious injury or medical follow up and that there was no impact to the patient or procedure.The procedures were completed.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Common Device Name: EYE PACK W-BLADES
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21365591
• Report Number: 1423395-2025-00010
• Device Sequence Number: 8452237
• Product Code: LRO
• UDI-Device Identifier: 10195327688240
• UDI-Public: 10195327688240
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/12/2025

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: DYNJ86904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/12/2025
• 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 Sex: Unknown