MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET 8065751922 manufactured by Alcon Research, Ltd. - Alcon Precision Device.
[49027360]
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
[49027361]
An ophthalmic surgeon reported that a patient experienced two or three posterior capsular tears during a surgical procedure. The surgeon stated that it happened because an irrigation and aspiration (i/a) tip was used even though it had a spike or splinter (burr) on the tip. Doctor will not provide further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523835-2016-00540 |
| MDR Report Key | 5776735 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-06-13 |
| Date Mfgr Received | 2016-06-13 |
| Date Added to Maude | 2016-07-07 |
| 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 | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| 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 | INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET |
| Generic Name | DEVICE, IRRIGATION, OCULAR SURGERY |
| Product Code | KYG |
| Date Received | 2016-07-07 |
| Model Number | NA |
| Catalog Number | 8065751922 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-07 |