MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2014-03-26 for MST CAPSULE RETRACTOR MCR-0001 manufactured by Microsurgical Technology, Inc..
[16224894]
During cataract surgery on a patient with loose zonules, an mst capsule retractor was threaded onto a capsular tension ring and had to be cut in order to be removed from the eye. The surgeon cut the loop portion of the retractor and removed both portions from the eye without impact to the patient. Post-op the patient was doing very well with uncorrected 20/25 vision and healing normally with a centered pciol in a stable capsular bag.
Patient Sequence No: 1, Text Type: D, B5
[16385928]
This incident was discovered during the investigation for report #3019924-2014-00009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2014-00010 |
| MDR Report Key | 3851282 |
| Report Source | 00,07 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-26 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2014-06-19 |
| 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 Street | 8415 154TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST CAPSULE RETRACTOR |
| Generic Name | OPHTHALMIC RETRACTOR |
| Product Code | HNI |
| Date Received | 2014-03-26 |
| Model Number | MCR-0001 |
| Catalog Number | MCR-0001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-26 |