MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-09 for MALYUGIN RING SYSTEM MAL-0001 manufactured by Microsurgical Technology Inc.
[5837252]
The surgeon reported that during cataract surgery on a patient with a traumatic eye injury that left the iris wispy the malyugin ring fell behind the iris and was left in the eye.
Patient Sequence No: 1, Text Type: D, B5
[13294337]
During surgery on an eye with a traumatic injury and a pupil that was described as 1mm and wispy the malyugin ring slipped behind the iris and was left in the capsular bag. Dr. (b)(6) stated he didn't want to do any further damage to the iris by removing the ring and chose to leave it in the eye. The patient had declined an iris repair procedure. The doctor was advised to remove the ring from the eye. Four weeks post-op the surgeon was able to remove the ring from the eye with the use of a new injector.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019924-2015-00020 |
| MDR Report Key | 4828945 |
| Report Source | 05 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-04 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-06-10 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALYUGIN RING SYSTEM |
| Generic Name | IRIS CLIP RETRACTOR |
| Product Code | HOC |
| Date Received | 2015-06-09 |
| Model Number | MAL-0001 |
| Catalog Number | MAL-0001 |
| 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. Required No Informationntervention | 2015-06-09 |