MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATARACT PACK

Catalog Number	VAL011CTASA
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye that the facility feels are coming from the back table cover.The facility reported that the event has occurred with eight patients.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, procedural, or retrieval details to the manufacturer.No sample has been received for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.This is report six of eight.
Event or Problem Description
It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye.

• Common Device Name: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8218886
• Report Number: 1423395-2018-00070
• Device Sequence Number: 13870769
• Product Code: OJK
• UDI-Device Identifier: 10889942021376
• UDI-Public: 10889942021376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: VAL011CTASA
• Device Lot Number: 18IBM853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other