MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for BACKFLUSH HANDLE DSP 337.88 manufactured by Alcon Grieshaber Ag.
[185789367]
No sample received at manufacturer. The device history records for the affected lots were reviewed. No abnormalities that could have contributed to this event were found and the products were released according to manufacturer's acceptance criteria. The manufacturer performs a 100% final inspection for this product. A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185789368]
A customer reported the soft tip was defective and fell off into the patient's eye. It is unconfirmed if the tip has been removed or it is retained in the patient's eye. Additional information has been requested but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2020-00024 |
| MDR Report Key | 9828643 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-05-14 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| 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 | 2020-03-13 |
| Model Number | NA |
| Catalog Number | 337.88 |
| Lot Number | F182024 |
| 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 | 2020-03-13 |