MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065420020 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[121435062]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[121435063]
A physician reported to the company representative that at the end of a cataract procedure a 30 gauge cannula shot off of the syringe and poked through the posterior capsule. He indicated the intraocular lens implant was in place and he completed the procedure. No additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2018-00410 |
| MDR Report Key | 7899825 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-09-21 |
| 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. - ALCON PRECISION DEVICE |
| Manufacturer Street | 714 COLUMBIA AVENUE |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-09-21 |
| Model Number | NA |
| Catalog Number | 8065420020 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-09-21 |