MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-14 for MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology, Inc..
[1153382]
Surgeon used malyugin ring to manage ifis condition during cataract procedure. The iol unfolded on top of the iris and when it was maneuvered into position, it disengaged the ring pushing it posteriorly and trapping it behind the iol.
Patient Sequence No: 1, Text Type: D, B5
[8381055]
The surgeon elected not to retrieve the ring. Early post-op examination showed very good results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2009-00003 |
| MDR Report Key | 1474563 |
| Report Source | 05 |
| Date Received | 2009-09-14 |
| Date of Report | 2009-09-12 |
| Date of Event | 2009-08-06 |
| Date Mfgr Received | 2009-08-13 |
| Date Added to Maude | 2011-03-31 |
| 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 NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2009-09-14 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| Lot Number | NOT PROVIDED |
| ID Number | NA |
| 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 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-14 |