MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC 8065149525 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[131127910]
No sample has been received by manufacturing for evaluation. 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. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131127911]
A director of surgical services reported that a piece of silicone fell from the tip of a soft-tipped cannula during vitrectomy surgery. The detached silicone tip was unable to be retrieved from the eye and was subsequently retained inside of the eye. Patient impact information is unknown. Additional information has been requested. Additional information received clarified that the patient condition is stable with no eye issues due to the retention of silicone tip in the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2018-00527 |
| MDR Report Key | 8182847 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2018-12-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| 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 | 2018-12-19 |
| Model Number | NA |
| Catalog Number | 8065149525 |
| Lot Number | 252086M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-19 |