MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751512 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[57402384]
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
[57402385]
A surgeon reported that during a procedure the irrigation/aspiration tip was getting hung up on the incision. This has occurred on two patients. Sutures were not required. There was no harm to the patient. This report is for the second patient from this facility.
Patient Sequence No: 1, Text Type: D, B5
[63859841]
No sample has been returned for evaluation for the report of hung up on incision; therefore, the condition of the product could not be verified. No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined. The manufacturer internal reference number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2016-00767 |
| MDR Report Key | 6014382 |
| Date Received | 2016-10-10 |
| Date of Report | 2017-01-04 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-12-07 |
| Date Added to Maude | 2016-10-10 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | 3 |
| Brand Name | DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2016-10-10 |
| Model Number | NA |
| Catalog Number | 8065751512 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 RESEARCH, LTD. - ALCON PRECISION DEVICE |
| Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-10 |