MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-04-05 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[71683697]
A sample has been received and in-house testing is in progress. 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)(4).
Patient Sequence No: 1, Text Type: N, H10
[71683698]
An ophthalmic surgeon reported that during the irrigation/aspiration (i/a) portion of a surgical procedure the patient experienced a capsule rupture. An anterior vitrectomy was performed to remove the vitreous present in the anterior chamber. It was noted that the surgeon suspects that there is a protrusion on the tip of the i/a cannula. The aspiration port was facing upward. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[80830677]
Two opened ia tips and three opened capsules were received in a plastic bag for the report of burr on tip. The samples were visually inspected. One sample was found conforming and one sample was non-conforming with a slice in the tip. A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product? S acceptance criteria. A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue. The returned non-conforming sample was received opened, loose in a bag; therefore, how and when the tip became damaged cannot be determined from this evaluation. The most likely contributing factor is damage from contact with another instrument during use. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2017-00229 |
| MDR Report Key | 6459675 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-05 |
| Date of Report | 2017-06-16 |
| Date Mfgr Received | 2017-06-07 |
| Device Manufacturer Date | 2016-12-14 |
| Date Added to Maude | 2017-04-05 |
| 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 | 2017-04-05 |
| Returned To Mfg | 2017-03-29 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | 179096M |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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; 2. Required No Informationntervention | 2017-04-05 |