MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EYE PACK 2

Catalog Number	VAL013EPFEK
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 3mm 15deg blade that comes in our packs have been dull multiple times.".
Additional Manufacturer Narrative
The customer reported that blades in custom cataract packs were dull, and no patient contact was noted.No sample or photo was received; the finished good production record was unable to be reviewed due to no lot number being provided, the pack's bill of materials was reviewed, and trending/component trending found 5 additional reported complaints for this issue in the past 24 months.Without a physical sample, medline was unable to determine the root cause and confirm the reported issue at this time.This complaint was provided to the vendor for further evaluation, the supplier quality team will monitor this issue for trending purposes, and further risk assessment found the incident acceptable w/ justification.There were no reports of death, serious injury, medical intervention, or follow up care.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-EYE PACK 2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50209340
• Report Number: 1417592-2026-15345
• Device Sequence Number: 20361248
• Product Code: LRO
• UDI-Device Identifier: 10195327657857
• UDI-Public: 10195327657857
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: VAL013EPFEK
• Device Lot Number: UNK PDM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 08/11/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown