MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for BURATTO BIMANUAL I/A SET 170.11 manufactured by Alcon Grieshaber Ag.
[100400058]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100400059]
An ophthalmic surgeon reported that during a vitrectomy procedure the patient experienced a posterior capsule tear. Additional information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2018-00003 |
| MDR Report Key | 7279696 |
| Date Received | 2018-02-19 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-06-06 |
| Date Added to Maude | 2018-02-19 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BURATTO BIMANUAL I/A SET |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2018-02-19 |
| Model Number | NA |
| Catalog Number | 170.11 |
| Lot Number | F91445 |
| ID Number | 7612717058286 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-19 |