MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-22 for MALYUGIN RING SYSTEM manufactured by Microsurgical Technology Inc.
[29010744]
The device was not returned for evaluation. No lot or part number information was available at the time of this report. The removal procedure was reported to have gone very well. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[29010785]
Upon insertion of an iol the haptic of the iol caught the malyugin ring scroll and pulled the entire malyugin ring into the capsular bag. A subsequent surgery was needed to remove the ring from the eye. There was no adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2015-00032 |
| MDR Report Key | 5169422 |
| Date Received | 2015-10-22 |
| Date of Report | 2015-10-21 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-10-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT MAY |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4255560544 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | CLIP, IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-10-22 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY INC |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-22 |