MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for SILICONE IRRIGATION AND ASPIRATION TIPS 8065740970 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[50174349]
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. The manufacturer internal reference number is: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[50174350]
A healthcare professional reported that the silicone irrigation and aspiration (i/a) tip had a crack on the tip which tore the patient's posterior capsular bag. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[58157474]
No i/a silicone tip sample has been returned for evaluation for the report of cracks or crease in tips - "tore a bag; 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. Because a sample was not returned and no lot information is available, the root cause for the customer complaint issue cannot be determined. The manufacturer internal reference number is: 2016-54281
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2016-00573 |
| MDR Report Key | 5813879 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-10-20 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-07-21 |
| 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. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| 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 | SILICONE IRRIGATION AND ASPIRATION TIPS |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2016-07-21 |
| Model Number | NA |
| Catalog Number | 8065740970 |
| Lot Number | ASKU |
| 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 | 2016-07-21 |