MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-24 for REFORM CAPSULAR TENSION RING ACTR11 manufactured by Morcher Gmbh.
[3859230]
A nurse reported that the surgeon noticed the capsular tension ring (ctr) was missing an eyelet upon inserting into the eye. The surgeon removed the ring and attempted to insert another tension ring. Upon inserting the second tension ring, it caused the bag to dehisce, and vitreous was lost. The nurse reported that it was difficult to remove the tension ring, which resulted in iris bleeding. Subsequently, the surgeon performed a vitrectomy, the tension ring was removed, and the pt was left add'l info was received from the surgeon who reported that he decided to use a ctr because there was some lens cortex left, but the zonules were very loose. The surgeon felt that the ctr would help to stabilize the capsular bag, and would facilitate the removal of the remaining lens cortex. In the surgeon's opinion, the ctr opened up and dehisced the capsular bag. The surgeon stated that a suture was also required to complete the procedure. A secondary surgical procedure has been planned to implant an intraocular lens in the pt's eye.
Patient Sequence No: 1, Text Type: D, B5
[11451204]
Eval summary - the product was returned for eval. The ring shows very slight scratches. The ring shows very slight scratches. The investigation of the ring shows no other faults/defects/deviations. The investigation of the container and the sealing tab showed no faults/defects/deviations. All measurements are within tolerances. Product met release criteria (excluding the very slight scratches). The measurement protocols show no irregularities in the dimensions. Reason of complaint cannot be confirmed, the cause is not related to the product. There has been one other complaint reported in the lot number. Attempts have been made to obtain add'l info by phone, fax and mail. A completed questionnaire was received on (b)(4) 2013. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2013-00034 |
| MDR Report Key | 3434413 |
| Report Source | 05 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-09-25 |
| Date Mfgr Received | 2013-09-25 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-10-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA KAY |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152605 |
| Manufacturer G1 | MORCHER GMBH |
| Manufacturer Street | KAPUZINERWEG 12 STUTTGART |
| Manufacturer City | WURTTEMBERG-BADEN D-70374 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-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 | CAPSULAR TENSION RING |
| Product Code | MRJ |
| Date Received | 2013-10-24 |
| Returned To Mfg | 2013-10-07 |
| Model Number | ACTR11 |
| Catalog Number | ACTR11 |
| Lot Number | BDCCBC |
| ID Number | NA |
| Device Expiration Date | 2018-03-31 |
| 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 GMBH |
| Manufacturer Address | KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-70374 GM D-70374 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-24 |