MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for DISPOSABLE ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE 8065750352 manufactured by Alcon Research, Ltd. - Houston.
[47629531]
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
[47629532]
A customer reported that the sleeve slid off the irrigation and aspiration tip during four eye procedures when sweeping the anterior capsule causing the anterior chamber to collapse. There was no patient harm associated with this event. A product sample was requested for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[54454047]
As the customer did not retain the finished goods lot number; a device history record review and lot history could not be conducted. The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted. It is important to remind the customer to return all products associated with the event for a full evaluation. The root cause of the customer's complaint could not be established as a sample has not been received. Without a sample, it is not possible to isolate the root cause. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2016-00868 |
| MDR Report Key | 5695657 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-09-12 |
| Date Mfgr Received | 2016-09-08 |
| Date Added to Maude | 2016-06-02 |
| 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 ANTERIOR VITRECTOMY COAXIAL IRRIGATION SLEEVE |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2016-06-02 |
| Model Number | NA |
| Catalog Number | 8065750352 |
| 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. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-02 |