MAUDE Adverse Event Report: MORCHER GMBH/ EMERGO GLOBAL REPRESENTATION LLC; RING, ENDOCAPSULAR

Model Number 2C V.1

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

During procedure, when loading 2 cionni rings with a capsular tension ring inserter, the distal eyelet was torn on both.The ring cannot be sutured into place with a torn eyelet, therefore the rings could not be used.A third ring was successfully used to complete the procedure as planned.No harm came to the patient.

• Brand Name: NA
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER GMBH/ EMERGO GLOBAL REPRESENTATION LLC; 2500 bee cave road; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 6348694
• MDR Text Key: 67946698
• Report Number: 6348694
• Device Sequence Number: 1
• Product Code: MRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: 2C V.1
• Device Lot Number: BFAAKA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 111