MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-06-30 for REFORM CAPSULAR TENSION RING ACTR11 manufactured by Morcher Stuttgart Gmbh.
[48616597]
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).
Patient Sequence No: 1, Text Type: N, H10
[48616598]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2016-00071 |
| MDR Report Key | 5762812 |
| Report Source | OTHER |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-03-02 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2016-09-17 |
| Date Added to Maude | 2016-06-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | MORCHER STUTTGART GMBH |
| Manufacturer Street | KAPUZINERWEG 12 |
| Manufacturer City | STUTTGART 70374 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 70374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFORM CAPSULAR TENSION RING |
| Generic Name | RING, ENDOCAPSULAR |
| Product Code | MRJ |
| Date Received | 2016-06-30 |
| Model Number | ACTR11 |
| Catalog Number | ACTR11 |
| Lot Number | BFJBHB |
| ID Number | Z00000380652257046 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORCHER STUTTGART GMBH |
| Manufacturer Address | KAPUZINERWEG 12 STUTTGART 70374 GM 70374 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-30 |