MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATARACT PACK-LF

Catalog Number	DYNJ0129784T
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) at the end of a cataract procedure, the product was being used to wick and blot fluid from the eye and the doctor noticed a fine white material/residue on his patient's eye after using the weck cel spears from the cataract back table packs.
Additional Manufacturer Narrative
According to the facility on (b)(6) at the end of a cataract procedure, the product was being used to wick and blot fluid from the eye and the doctor noticed a fine white material/residue on his patient's eye after using the weck cel spears from the cataract back table packs.The eye needed to be rinsed with balanced salt solution, to remove residue.The facility stated that balanced salt solution is a type of irrigation commonly used during ophthalmology procedures.The procedure was able to be completed.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CATARACT PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20674709
• Report Number: 1423395-2024-00498
• Device Sequence Number: 15684016
• Product Code: OJK
• UDI-Device Identifier: 40198459049935
• UDI-Public: 40198459049935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ0129784T
• Device Lot Number: 24HMB533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/13/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown