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

Catalog Number	VAL001CPMEC
Medical Device Problem Codes	Material Deformation (2976); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they said they appear to be crimped and causing a double barrel stream, and dr.Said at times nothing will push through.".
Additional Manufacturer Narrative
The customer reported issues with the hydrodissectors in the packs: they appear to be crimped and causing a double barrel stream, and at times nothing will push through; the issue was noticed prior to patient contact and there was no impact to any of the patient.A photo and a sample were received, several photos were provided, the bill of materials and production record were reviewed, and visual evaluation showed that several cannulas exhibited a forked or "double barreled" appearance.Based on review of the reported complaint, sample evaluation, photographic evidence, bill of materials, and production records, the reported issue was confirmed.The correction states, "this is a manufacturing process issue," and the pack build review found nothing that may have contributed to the reported defect, with the component received from the vendor and placed into the pack with no alteration by medline during the production process.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: CATARACT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771494
• Report Number: 1417592-2026-40308
• Device Sequence Number: 13117900
• Product Code: OJK
• UDI-Device Identifier: 10198459435379
• UDI-Public: 10198459435379
• 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): 09/14/2026

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: VAL001CPMEC
• Device Lot Number: 25JBK650
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2026
• 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: 01/12/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown