MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATARACT MALIK

Catalog Number	DYNJ903206I
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2025 "syringes graduations were twisted and not straight".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "syringes graduations were twisted and not straight".Per the facility there was no patient involvement and the out of spec syringe was noticed prior to patient use.The sample was returned for evaluation, and the product defect was confirmed.No additional information is available at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for (b)(6) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: CATARACT MALIK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21397721
• Report Number: 1423395-2025-00015
• Device Sequence Number: 15755301
• Product Code: OJK
• UDI-Device Identifier: 10198459027161
• UDI-Public: 10198459027161
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/18/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: DYNJ903206I
• Device Lot Number: 24GDA149, 24GDB288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown