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

Model Number LYN003EYUPA

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 03/08/2022

Event Type  Injury  

Event Description

According to the facility a fiber was discovered post cataract procedure and needed an additional procedure to remove the fiber.

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.
• Type of Device: 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
• MDR Text Key: 290921875
• Report Number: 1423395-2022-00017
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10193489374445
• UDI-Public: 10193489374445
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LYN003EYUPA
• Device Catalogue Number: LYN003EYUPA
• Device Lot Number: 21LBD671
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male