MAUDE Adverse Event Report: MORCHER STUTTGART GMBH REFORM CAPSULAR TENSION RING; RING, ENDOCAPSULAR

Model Number ACTR11

Device Problem Break (1069)

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

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other similar complaints reported in the lot number.The reporter did not provide any contact information; therefore, follow up was not able to be conducted.(b)(4).

Event Description

A facility representative reported via reply card that a capsular tension ring was removed - broke capsular bag.The reporter did not provide any contact information; therefore, follow up was not able to be conducted.

• Brand Name: REFORM CAPSULAR TENSION RING
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer (Section G): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5762812
• MDR Text Key: 48616597
• Report Number: 1610287-2016-00071
• Device Sequence Number: 1
• Product Code: MRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: ACTR11
• Device Catalogue Number: ACTR11
• Device Lot Number: BFJBHB
• Other Device ID Number: Z00000380652257046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR