MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-17 for MST MALYUGIN RING SYSTEM MAL-1002 manufactured by Microsurgical Technology Inc.
[82976936]
The doctor noticed the capsule tear towards the end of the procedure after the iol had been implanted. It is unclear why the malyugin ring was implicated as the cause. The device evaluation showed that there were no burrs or sharp edges present on the device. This complaint cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[82976937]
The sales rep reported that the surgeon noticed a capsule tear after inserting an iol. A sulcus lens was used and the procedure was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2017-00010 |
| MDR Report Key | 6802951 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2017-08-17 |
| 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. ROB RANEY |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST MALYUGIN RING SYSTEM |
| Generic Name | IRIS RETRACTOR |
| Product Code | HOC |
| Date Received | 2017-08-17 |
| Returned To Mfg | 2017-07-20 |
| Model Number | MAL-1002 |
| Catalog Number | MAL-1002 |
| Lot Number | 087216 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-17 |