MAUDE Adverse Event Report: MORCHER GMBH FORTIFEYE CAPSULAR TENISON RING (CTR); RING, ENDOCAPSULAR

Model Number CTR11R

Device Problem Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2023

Event Type  Injury  

Event Description

It was reported that the capsular tension ring did not release as intended, and the device had to be cut with scissors to be retracted.The surgeon, then performed an anterior vitrectomy and the patient was left aphakic.The incision was not enlarged as a result, and sutures were not required.

• Brand Name: FORTIFEYE CAPSULAR TENISON RING (CTR)
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• MDR Report Key: 17802135
• MDR Text Key: 324112096
• Report Number: 0001313525-2023-70110
• Device Sequence Number: 1
• Product Code: NCE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2023,08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CTR11R
• Device Catalogue Number: CTR11R
• Device Lot Number: CCCCFB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2023
• Distributor Facility Aware Date: 08/23/2023
• Device Age: 18 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/22/2023
• Date Manufacturer Received: 08/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention