MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2012-09-01 for MALYUGIN RING SYSTEM MAL-0002 manufactured by Microsurgical Technology, Inc..
[19695189]
The surgeon experienced a capsule tear while using the malyugin ring during an explant of an iol.
Patient Sequence No: 1, Text Type: D, B5
[19784778]
The surgeon indicated this was a complicated explant of an older iol. The capsulorhexis had already been performed and the capsule was difficult to see around the iris and was torn when the ring was inserted. No vitreous loss and no follow up was planned. This report was sent to mst from a third party manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2012-00035 |
| MDR Report Key | 2748722 |
| Report Source | 00,05,06 |
| Date Received | 2012-09-01 |
| Date of Report | 2012-09-01 |
| Date of Event | 2012-08-06 |
| Date Mfgr Received | 2012-08-06 |
| Date Added to Maude | 2012-12-18 |
| 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 |
| 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 | 2012-09-01 |
| Model Number | MAL-0002 |
| Catalog Number | MAL-0002 |
| Lot Number | UNKNOWN |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-01 |