MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-10-30 for CUSTOM PAK manufactured by Alcon - Houston.
[967720]
The customer reported that they had a fiber in the eye on the event date, found during post op visit the following day, and the second surgery was in 2008, to remove the fiber. The fiber was white with blue tint. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8209610]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary when additional reportable information becomes available. This report was mailed to fda on: 10/30/2008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2008-00032 |
| MDR Report Key | 1216654 |
| Report Source | 05,07 |
| Date Received | 2008-10-30 |
| Date of Report | 2008-09-26 |
| Date of Event | 2008-09-24 |
| Date Mfgr Received | 2008-09-24 |
| Date Added to Maude | 2008-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| Manufacturer G1 | ALCON - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM PAK |
| Generic Name | CONVENIENCE KIT |
| Product Code | HMT |
| Date Received | 2008-10-30 |
| Model Number | CUSTOM PAK |
| Catalog Number | CUSTOM PAK |
| Lot Number | 830731H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1266169 |
| Manufacturer | ALCON - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-30 |