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

Catalog Number	DYNJ62204A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during follow up after an unidentified eye procedure, the gauze was identified to have linted into the patient's eye.The linted material was required to be retrieved from the patient's eye during the follow up visit by the clinician.After multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the pack manufacturer.No impact or adverse effect to the patient was originally reported to the pack manufacturer.The actual pack involved in the reported incident was not returned to the pack manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention to retrieve the linted gauze material from the patient's eyes, 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 the gauze linted into the patients eye during an unidentified eye procedure.

• Common Device Name: CATARACT PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8955888
• Report Number: 1423395-2019-00031
• Device Sequence Number: 14064573
• Product Code: OJK
• UDI-Device Identifier: 10193489633474
• UDI-Public: 10193489633474
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ62204A
• Device Lot Number: 19CBR358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: Required Intervention