MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL INC CANNULA VISCOFLOW 30GA 9MM BEND 10/SP

Model Number 585046

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Retinal Tear (2050)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided upon the investigation completion.

Event Description

Md was doing cataract surgery when the 585046 visco cannula, was used to inject bss after phacoemulsification, when it ejected and caused a retinal tear.An in-house retinal surgeon saw the patient immediately and referred the patient to another retinal surgeon that day.The retinal surgeon repaired the retinal tear and placed silicone oil into the eye.

• Brand Name: CANNULA VISCOFLOW 30GA 9MM BEND 10/SP
• Type of Device: CANNULA VISCOFLOW 30GA 9MM BEND 10/SP
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL INC; 500 totten pond rd; 10 citypoint; waltham MA 02451 1916
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL INC; valle de los cedros 1520; juarez, chihuahua 32575 ; MX 32575
• Manufacturer Contact: agnieszka drzewiecka ; 500 totten pond rd; 10 citypoint; waltham, ma 02451-1916 ; MX 024511916
• MDR Report Key: 18752535
• MDR Text Key: 335933341
• Report Number: 1211998-2024-00004
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 585046
• Device Lot Number: 6062572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention