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

Model Number DYNJ82650

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/15/2022

Event Type  Injury  

Event Description

According to the facility on (b)(6) 22 during an "uneventful phaco surgery, while hydrating the main wound the cannula flew off the syringe puncturing through the iris and the posterior capsule.".

Manufacturer Narrative

According to the facility on (b)(6) 22 during an "uneventful phaco surgery, while hydrating the main wound the cannula flew off the syringe puncturing through the iris and the posterior capsule." per the facility "an anterior vitrectomy had to be performed in order to clear out the blood and vitreous that came forward through the opened posterior capsule." the facility stated "the eye was closed with several sutures to ensure a tight seal of the wound." no additional information is available at this time.The sample has not been returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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: PHACO EYE PACK
• 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: 16280270
• MDR Text Key: 308588706
• Report Number: 1423395-2023-00003
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10195327199234
• UDI-Public: 10195327199234
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ82650
• Device Catalogue Number: DYNJ82650
• Device Lot Number: 22HBO903
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2023
• 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