MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for HENDERSON CAPSULAR TENSION RING 10 C manufactured by Emergo Global Representation Llc.
[117472858]
Preoperative diagnosis: cataract, right eye. Procedure(s) performed: phacoemulsification with posterior chamber intraocular lens implantation. During procedure, the trailing end of morcher capsular tension ring broke off into three pieces upon insertion into operative eye by surgeon. The surgeon removed broken pieces of capsular tension ring out of the operative eye with no injury to patient. Follow-up: product concern reported out. Remaining stock items with the same lot number were removed from stock supply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7793022 |
| MDR Report Key | 7793022 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-07-02 |
| Report Date | 2018-07-16 |
| Date Reported to FDA | 2018-07-16 |
| Date Reported to Mfgr | 2018-08-17 |
| Date Added to Maude | 2018-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENDERSON CAPSULAR TENSION RING |
| Generic Name | RING, ENDOCAPSULAR |
| Product Code | MRJ |
| Date Received | 2018-08-17 |
| Catalog Number | 10 C |
| Lot Number | BEGBAA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMERGO GLOBAL REPRESENTATION LLC |
| Manufacturer Address | 2500 BEE CAVE ROAD, BLDG 1, STE 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |