MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-09 for ALLEGRO SP ASP-0001-R manufactured by Microsurgical Technology.
[141372731]
The returned device was evaluated and found to be within specification. After further investigation and interview with the surgeon it was determined that the ia settings used were not appropriate. After an adjustment to the settings, no further problems were experienced. Visual acuity for the patient is 20/20-1 at one month post op.
Patient Sequence No: 1, Text Type: N, H10
[141372732]
After removal of the cataract, at the very beginning of polishing a small opening was noted in the posterior capsule. Capsular support was intact, and no vitreous prolapse was noted. Iol place in the capsular bag with excellent lens centration and stability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019924-2019-00003 |
| MDR Report Key | 8496818 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-05 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-03-21 |
| Date Added to Maude | 2019-04-09 |
| 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. CECIL CHRISINGER |
| Manufacturer Street | 8415 154TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252846094 |
| Manufacturer G1 | MICROSURGICAL TECHNOLOGY |
| 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 | ALLEGRO SP |
| Generic Name | OPHTHALMIC CANNULA |
| Product Code | HMX |
| Date Received | 2019-04-09 |
| Returned To Mfg | 2019-04-02 |
| Model Number | ASP-0001-R |
| Catalog Number | ASP-0001-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROSURGICAL TECHNOLOGY |
| Manufacturer Address | 8415 154TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-09 |