MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-22 for ULTRAFLOW BIMANUAL I/A HANDPIECE SET DSP 170.71 manufactured by Alcon Grieshaber Ag.
[114670448]
A sample was not received for evaluation. The device history record for the affected lot was reviewed. No abnormalities that could have contributed to this event were found and the product was released according to acceptance criteria. A 100% final inspection for this product was performed. A root cause cannot be determined with the information obtained. Various causes are possible for this kind of potential damage. The manufacturer will continue to monitor data for evidence of adverse trends and take further action, as appropriate. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114670449]
A surgeon reported that the patient experienced a right eye equatorial capsular rupture due to a rough irrigation/aspiration handpiece tip during a cataract procedure. A pars plana vitrectomy was performed, explantation of the intraocular lens and a secondary intraocular lens was implanted in the sulcus. The patient was hospitalized for two days following the procedure. The event has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2018-00014 |
| MDR Report Key | 7709474 |
| Date Received | 2018-07-22 |
| Date of Report | 2018-07-22 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2018-01-12 |
| Date Added to Maude | 2018-07-22 |
| 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. BRYAN BLAKE |
| 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 | ULTRAFLOW BIMANUAL I/A HANDPIECE SET DSP |
| Generic Name | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED |
| Product Code | HQR |
| Date Received | 2018-07-22 |
| Model Number | NA |
| Catalog Number | 170.71 |
| Lot Number | F158436 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-07-22 |