MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) 8065750957 manufactured by Alcon Research, Ltd. - Houston.
[125282002]
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
[125282003]
A nurse reported the surgeon experienced a disconnection between the viscous fluid control syringe and it's tube during a silicone oil removal procedure and laser procedure of the left eye. When the disconnection occurred, the complete trocar went into the eye and it created a large incision. The trocar was removed during the same surgical session. The surgeon indicated there was no damage to the retina and "regular" stitching was performed at the end of the procedure. There was no harm to the patient. This report is associated with the trocar dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644019-2018-00255 |
| MDR Report Key | 8010927 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-10-26 |
| 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 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 | 0 |
| Brand Name | VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-11-17 |
| Model Number | NA |
| Catalog Number | 8065750957 |
| Lot Number | 2120841H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-26 |