MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-20 for DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS 8065751511 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[80518465]
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
[80518466]
A doctor reported that an irrigation / aspiration tip presented with a burr during a procedure. The patient experienced a posterior capsular rupture. Additional information has been requested but none has been received.
Patient Sequence No: 1, Text Type: D, B5
[107645561]
One polymer angled i/a tip was returned for evaluation for the report of burr inside the tip that resulted in a capsule tear. A review of the device history records 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 were no additional complaints associated with the lot for the reported issue. A visual inspection was performed and deemed conforming. A small amount of dried surgical material was present along the bottom left side of the port hole, which has the appearance of burr. The material was removed and no burr was present within the aspiration hole. The complaint evaluation does not confirm the polymer ia tip has nonconforming burr in the aspiration port and was the reason for the capsule tear. The tip was manufactured to specification. The reason for the capsule tear cannot be determined from this evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2017-00595 |
| MDR Report Key | 6727681 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-20 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-10-09 |
| Device Manufacturer Date | 2017-05-30 |
| Date Added to Maude | 2017-07-20 |
| 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. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | 2017-07-20 |
| Returned To Mfg | 2017-07-27 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | 198445M |
| Device Expiration Date | 2019-04-30 |
| 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 | 2017-07-20 |