Brand Name | AIR OPTIX COLORS |
Type of Device | LENSES, SOFT CONTACT, DAILY WEAR |
Manufacturer (Section D) |
CIBA VISION JOHOR SDN, BHD. |
#1 dpb/5 tanjung pelepas port |
gelang patah |
johor darul takzim johor 81560 |
MY 81560 |
|
Manufacturer (Section G) |
CIBA VISION JOHOR SDN, BHD. |
#1 dpb/5 tanjung pelepas port |
gelang patah |
johor darul takzim johor 81560 |
MY
81560
|
|
Manufacturer Contact |
nadia
bailey
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152230
|
|
MDR Report Key | 6826924 |
MDR Text Key | 83869013 |
Report Number | 3006186389-2017-00076 |
Device Sequence Number | 1 |
Product Code |
LPL
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K133176 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,other |
Reporter Occupation |
Patient
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
08/29/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/30/2018 |
Device Lot Number | 10282486 |
Other Device ID Number | 000000000010095322-155673380 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/01/2017 |
Initial Date FDA Received | 08/29/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/18/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 53 YR |
|
|