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

Model Number	DYNJ82650
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 1/9/23 during a cataract procedure the physician "was hydrating the main wound and the cannula came off of the syringe and punctured the iris and the posterior capsule".Per the facility "they had to remove the cannula from the eye, perform an anterior vitrectomy, reposition the lens and constrict the pupil".Per the facility "the scrub tech checked that the cannula and syringe were attached".The facility stated the procedure was able to be completed, but there is some "retinal bleeding at post-operative week 2 that may be related to the cannula injury".The sample is not available to be returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
According to the facility on 1/9/23 during a cataract procedure the physician "was hydrating the main wound and the cannula came off of the syringe and punctured the iris and the posterior capsule".

• Brand Name: Medline Industries, Inc.
• Common Device Name: 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: 16273622
• Report Number: 1423395-2023-00002
• Device Sequence Number: 18030967
• Product Code: OJK
• UDI-Device Identifier: 10195327199234
• UDI-Public: 10195327199234
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYNJ82650
• Device Catalogue Number: DYNJ82650
• Device Lot Number: 22HBO903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/31/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male