MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; EYE PACK UPMC

Model Number	LYN003EYUPA
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility a fiber was discovered post cataract procedure and needed an additional procedure to remove the fiber.
Additional Manufacturer Narrative
According to the facility a fiber was discovered post cataract procedure and needed an additional procedure to remove the fiber.Per the facility the patient's cataract procedure was performed on (b)(6) 2022 and during a post op visit it was stated the patient had inflammation in the right eye and a foreign body was discovered.Per the facility, surgical removal was needed in order for the foreign body to be removed.The procedure was performed on (b)(6) 2022 and the foreign body was removed from the anterior chamber of the right eye by opening the prior incision from the cataract surgery.No additional sutures were needed to close the incision and per the facility they expect "excellent recovery with normal visual recovery".The sample is not available to be returned for evaluation.No additional information is currently available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: EYE PACK UPMC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14289350
• Report Number: 1423395-2022-00017
• Device Sequence Number: 5408017
• Product Code: OJK
• UDI-Device Identifier: 10193489374445
• UDI-Public: 10193489374445
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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 Model Number: LYN003EYUPA
• Device Catalogue Number: LYN003EYUPA
• Device Lot Number: 21LBD671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male