MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[73378037]
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
[73378038]
A health professional reported that a irrigation / aspiration (i/a) tip broke during the i/a portion of a surgery. The surgery was completed. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
[96880219]
One opened i/a tip was received in a plastic bag for the report of broken tip. The sample was visually inspected and was found non-conforming with the tip and cannula missing. The metal cannula was present inside of the hub. No lot number was identified with this complaint; therefore, a lot history review could not be conducted. The evaluation confirmed a broken tip as reported. Part of the cannula was present inside of the hub showing that the cannula was molded to the hub prior to release from the manufacturing site. It is also mentioned in the complaint file that the cannula was broken during the procedure. The part of the tip that was broken off was discarded and was not returned to the investigation site, therefore an exact root cause of the break cannot be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2017-00295 |
| MDR Report Key | 6503459 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-04-19 |
| 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 |
| 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 | 0 |
| Brand Name | DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2017-04-19 |
| Returned To Mfg | 2017-05-19 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | ASKU |
| 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 | 2017-04-19 |