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

Catalog Number	DYNJ60113
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that at the beginning of the eye/cataract/iol/implant procedure, when the patient's eye was looked at under a microscope, it was discovered by the physician that there was a lint particulate floating on patient's lens.The lint particulate was reportedly possibly from the gauze located in the prep tray from the custom surgical pack (eye pack).It was added that the lint particulate reached the patient's eye/lens when medication from the medicine cup was administered to the patient's eye.Per report, the custom surgical pack's integrity was verified prior to use and the lint particulate was not identified in the medicine cup at that time.It was reported that irrigation was required to remove the lint particulate from the patient's eye/lens.The patient was under sedation at the time of the incident and there was no report of additional sedation medication required.Immediately in the post-operative phase, the patient was reportedly well.No impact to the patient, the procedure, or the total length of the procedure was reported.There was no serious injury or follow up care reported related to the event.Due to the reported incident and medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that irrigation was required to remove the lint particulate that was discovered floating on the patient's lens.

• Common Device Name: GAUZE FROM EYE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8147723
• Report Number: 1423395-2018-00063
• Device Sequence Number: 295858
• Product Code: OJK
• UDI-Device Identifier: 10888277799905
• UDI-Public: 10888277799905
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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: DYNJ60113
• Device Lot Number: 18HDB581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/10/2018
• 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