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 2017-03-15 for MST CAPSULE RETRACTORS MCR-0001 manufactured by Microsurgical Technology Inc.
[70056472]
The patient had preexisting conditions that included subluxated crystalline lens and 360 degrees of zonular deficiency. The surgeon indicated that the capsule retractor was able to stabilize the subluxated lens enough to complete removal of the cataractous lens however due to complete zonular deficiency the retractors had to be repositioned for stability resulting in the capsule tear and subsequent vitrectomy. An iol was able to placed via suture in a second surgery. Device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[70056473]
During cataract surgery the surgeon experienced an anterior capsule tear resulting in a vitrectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2017-00004 |
| MDR Report Key | 6407779 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2017-03-15 |
| 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. JOHN RAY |
| 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 CAPSULE RETRACTORS |
| Generic Name | RETRACTOR, OPHTHALMIC |
| Product Code | HNI |
| Date Received | 2017-03-15 |
| Model Number | MCR-0001 |
| Catalog Number | MCR-0001 |
| Lot Number | 069569 |
| Device Expiration Date | 2017-06-01 |
| 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 | 2017-03-15 |