MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for ALCON MICROSURGICAL ANTERIOR CHAMBER CANNULA 30 GA DISPOSABLE 8065420020 manufactured by Alcon Research, Ltd..
[118461588]
There seems to be a product issue or design with the alcon. Microsurgical instrument anterior chamber cannula 30 ga disposable ref #8065420020 (will be stated as cannula). You must connect the cannula to the luer loc syringe. When the plunger is pushed on the syringe, to irrigate, the "slightest" pressure causes the cannula to become disengaged from the luer lc syringe. Currently there are no other options or products that have one continuous connection for this device that is used for ophthalmology surgical procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079418 |
| MDR Report Key | 7818871 |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-23 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALCON MICROSURGICAL ANTERIOR CHAMBER CANNULA 30 GA DISPOSABLE |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-08-24 |
| Model Number | 8065420020 |
| Catalog Number | 8065420020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. |
| Manufacturer Address | FORT WORTH TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-24 |