MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for REFORM CAPSULAR TENSION RING ACTR12 manufactured by Morcher Stuttgart Gmbh.
[40832574]
Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. The device was not returned for analysis. Attempts have been made to obtain additional information by phone and email. A completed questionnaire was received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40832575]
During an intraocular lens (iol) implant surgery, a healthcare worker reported a capsular tension ring (ctr) to have stripped zonular support when inserted. The ctr was removed during the initial procedure. One day postoperatively the iol was decentered and repositioned. Another ctr was successfully placed.
Patient Sequence No: 1, Text Type: D, B5
[45711902]
Evaluation summary: the device was returned for analysis. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2016-00021 |
| MDR Report Key | 5514592 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-04-27 |
| Date Added to Maude | 2016-03-21 |
| 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 | 2016-03-21 |
| Model Number | ACTR12 |
| Catalog Number | ACTR12 |
| Lot Number | ASKU |
| ID Number | 00380652257053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Required No Informationntervention | 2016-03-21 |