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

Catalog Number	DYNJ50948
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified ophthalmic procedure, fibers from an unidentified component were found to have fallen into the patient's eye.The facility was contacted and was unable to identify if the fibers came from a gown or an operating room towel.The facility noted that there was no patient impact related to this incident and that they are unable or unwilling to provide any additional patient, product, or procedural information.It was not identified which eye the fibers fell on.It was not identified how the fibers were retrieved.No procedural impact, serious injury, or follow-up care was originally reported to the manufacturer.A sample of unopened operating room towels was returned to the manufacturer and lint was noted on the operating room towels only.It is unknown how the operating room towels were used during the procedure.No sample of a gown was returned to the manufacturer for evaluation.It is unknown at what point in the procedure the fibers were identified.A root cause for the reported incident could not be determined.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.
Event or Problem Description
It was reported that during an unidentified ophthalmic procedure, fibers from an unidentified component were found to have fallen into the patient's eye.

• Common Device Name: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8019476
• Report Number: 1423395-2018-00057
• Device Sequence Number: 1381825
• Product Code: OJK
• UDI-Device Identifier: 10889942106028
• UDI-Public: 10889942106028
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/30/2018

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: Health Professional
• Device Catalogue Number: DYNJ50948
• Device Lot Number: 18NB3371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/30/2018
• 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: Other; Required Intervention