MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-26 for MST CAPSULE RETRACTOR MCR-0001 manufactured by Microsurgical Technology, Inc..
[4614975]
During cataract surgery on a patient with loose zonules, an mst capsule retractor was threaded onto a capsulor tension ring and was not able to be removed from the eye. The surgeon cut the capsule retractor close to the periphery and tucked the end of the retractor under the iol and removed the remaining portion of the retractor. Post-op the patient was doing well and healing normally with the piece of retractor still behind the centered iol.
Patient Sequence No: 1, Text Type: D, B5
[12016618]
During the course of investigating this incident a similar issue was identified and will be submitted on report number 3019924-2014-00010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2014-00009 |
| MDR Report Key | 3851286 |
| Report Source | 05 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2014-06-20 |
| 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 |