MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-12 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[62391835]
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
[62391836]
A nurse reported that an irrigation / aspiration (i/a) cannula split into two parts during a surgery. The cannula was exchanged to complete the case. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
[68135941]
Additional information provided in model #/lot #, device available for evaluation? , and concomitant medical products. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71380604]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71380605]
New information received from the customer stating the suspect product is not an irrigation / aspiration tip which was originally reported. It is a phacoemulsification tip.
Patient Sequence No: 1, Text Type: D, B5
[73013525]
One balance phaco tip was returned for evaluation for the report of a split cannula into two parts. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. A visual inspection of the phaco tip received was performed and deemed nonconforming. The tip is broken along the cannula. The break extends from the back of the cannula up to the bend region. The wall thickness at the break area is uneven, causing a thin wall. The complaint does confirm the phaco tip is broken. The reason for the breakage is due to a nonconforming thin wall present at the break area. This thin wall is a manufacturing issue created at the machining process for the phaco tip. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2016-00916 |
| MDR Report Key | 6166456 |
| Date Received | 2016-12-12 |
| Date of Report | 2017-04-06 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2017-04-05 |
| Date Added to Maude | 2016-12-12 |
| 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. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| 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 | 2016-12-12 |
| Returned To Mfg | 2016-12-22 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-12-12 |