MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-12 for MST CAPSULE RETRACTOR MCR-0002 manufactured by Microsurgical Technology Inc.
[94528860]
A video presentation from a trade show was reviewed. While removing a hard cataract, capsule retractors were used to stabilize weak zonules. During surgery one of the capsule retractors slipped off of the capsule. After this occured a capsule tear was noticed and a vitrectomy was required. A three piece lens was used to complete the surgery. No device was returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[94528861]
During cataract surgery the surgeon experienced an anterior capsule tear resulting in a vitrectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2017-00021 |
| MDR Report Key | 7108568 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-12 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-12-12 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MST CAPSULE RETRACTOR |
| Generic Name | RETRACTOR, OPHTHALMIC |
| Product Code | HNI |
| Date Received | 2017-12-12 |
| Model Number | MCR-0002 |
| Catalog Number | MCR-0002 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-12-12 |