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

Catalog Number	LYN035CTMVI
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device "has holes in the pack.".
Additional Manufacturer Narrative
The account reported finding hole in pack; the complaint also stated there was no patient contact and no injury occurred.No sample or photo received for the investigation; the production record for the reported lot was reviewed and there were no line downs, deviations, or non-conformances reported that might have had an impact on this issue, the bill of materials (bom) and pack build were reviewed and no issues were identified, and trending was reviewed with 0 additional reported complaint(s) for this issue for the account in the past 24 months.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation; the cause was unconfirmed and a sample was required to determine cause.The division will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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-CATARACT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819441
• Report Number: 1417592-2026-44768
• Device Sequence Number: 13440055
• Product Code: OJK
• UDI-Device Identifier: 10193489281989
• UDI-Public: 10193489281989
• 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): 09/17/2026

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: LYN035CTMVI
• Device Lot Number: 25BBU034
• 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: 09/22/2025
• Initial Report FDA Received Date: 09/18/2026
• 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