MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.
[66723194]
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
[66723195]
A nurse manager reported that during a vitrectomy procedure, the surgeon indicated that the cannula disconnected from the syringe when exerting pressure to infuse the silicone oil. This occurred with two different units. The procedure was completed by infusing the silicone oil slowly and with the assistance of forceps to hold the connection. The product samples were not retained. There was no patient harm. Additional information was requested; however, none has been received to date.
Patient Sequence No: 1, Text Type: D, B5
[76057413]
The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue. The device history record showed the product was released per specifications. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted. The root cause of the customer's complaint could not be established as a sample has not been received. Potential root causes could be related to surgical technique or manufacturing related issue, however, this cannot be confirmed with the information available. After a thorough investigation of this complaint, it has been determined that no action will be taken at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2017-00111 |
| MDR Report Key | 6299125 |
| Date Received | 2017-02-03 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-28 |
| Device Manufacturer Date | 2016-09-02 |
| Date Added to Maude | 2017-02-03 |
| 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. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2017-02-03 |
| Model Number | NA |
| Catalog Number | 8065750957 |
| Lot Number | 1926002H |
| ID Number | NA |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-03 |