MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-06 for BACKFLUSH HANDLE DSP 337.88 manufactured by Alcon Grieshaber Ag.
[174292034]
No sample or lot number information has been received by manufacturing for evaluation. As the affected lot is unknown, the device history record could not be reviewed, but a 100% final inspection is performed for this product. A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation. The sample is not available for investigation because it was discarded therefore, damage cannot be confirmed or rather a root cause cannot be identified. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174292035]
A physician reported that the silicone tip of an ophthalmic backflush device detached into a patient's eye during vitrectomy surgery and was retained inside of the eye. An additional surgical procedure was required and performed in order to remove the detached tip from inside of the eye. There was no harm to the patient. Additional information received further clarified that the detached device tip was removed from the eye during a separate surgery that was performed on a later date. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2020-00005 |
| MDR Report Key | 9553448 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-06 |
| 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. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| 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 | 3 |
| Brand Name | BACKFLUSH HANDLE DSP |
| Generic Name | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY |
| Product Code | HQE |
| Date Received | 2020-01-06 |
| Model Number | NA |
| Catalog Number | 337.88 |
| Lot Number | ASKU |
| 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 GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-06 |