Brand Name | CUSTOM PAK |
Type of Device | CONVENIENCE KIT |
Manufacturer (Section D) |
ALCON - HOUSTON |
9965 buffalo speedway |
houston TX 77054 |
|
Manufacturer (Section G) |
ALCON - HOUSTON |
9965 buffalo speedway |
|
houston TX 77054 |
|
Manufacturer Contact |
janet
moran
|
6201 south freeway, r3-48 |
fort worth, TX 76134
|
8176152742
|
|
MDR Report Key | 4505935 |
MDR Text Key | 5528665 |
Report Number | 2028159-2015-00225 |
Device Sequence Number | 1 |
Product Code |
KYG
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/13/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/26/2016 |
Device Model Number | CUSTOM PAK |
Device Catalogue Number | CUSTOM PAK |
Device Lot Number | 1587142H |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/13/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | INFINITI VISION SYSTEMS; VISCOELASTICS |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 86 YR |