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

Model Number DYNJ53019A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that a metal fleck was found under a microscope by a physician.

Manufacturer Narrative

It was reported that a metal fleck was found under a microscope by a physician during an unspecified procedure.Reportedly, the physician believed it came from a 27g cannula.To date, no information has been received to indicate that a syringe caused or contributed to the reported problem/issue.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.At this time, no sample has been provided for evaluation.A root cause for the reported problem/issue was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 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.

Manufacturer Narrative

Update made to d2 product information.

Event Description

It was reported that a metal fleck was found under a microscope by a physician.

• Type of Device: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18826500
• MDR Text Key: 336781024
• Report Number: 1423395-2024-00112
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 40889942582762
• UDI-Public: 40889942582762
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ53019A
• Device Lot Number: 23KDB939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other