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

Catalog Number	DYNJ53299A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an unknown number of patients undergoing cataract extraction had blue fibers/particulates falling in their eyes which were retrieved using instruments by the surgeon.Reportedly, the particulates were microscopic and were not visible during initial product inspection prior to use.The reporting facility believed the blue fibers/particulates were possibly from the table cover and transferred into the patients' eyes through the instruments that were used for the procedure.It was reported that the patients were treated with steroids for corneal edema and inflammation but it wasn't sure if this was due to the blue fibers/particulates.Monitored anesthesia care was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No sample was available to be returned for evaluation.The complaint cannot be confirmed.A root cause cannot be identified at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.No additional information was provided.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unknown number of patients undergoing cataract extraction had blue fibers/particulates falling in their eyes.

• Common Device Name: EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7400268
• Report Number: 1423395-2018-00019
• Device Sequence Number: 37851
• Product Code: OJK
• UDI-Device Identifier: 10889942475940
• UDI-Public: 10889942475940
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ53299A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/05/2018
• 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: Required Intervention