Brand Name | ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY |
Type of Device | LENSES, SOFT CONTACT |
Manufacturer (Section D) |
JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND |
one technological park plassey |
limerick |
EI |
|
Manufacturer Contact |
rose
harrell
|
7500 centurion parkway |
jacksonville, FL 32256
|
9044433364
|
|
MDR Report Key | 7238091 |
MDR Text Key | 98912968 |
Report Number | 9617710-2018-05012 |
Device Sequence Number | 1 |
Product Code |
LPL
|
Combination Product (y/n) | N |
Reporter Country Code | RS |
PMA/PMN Number | K042275 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/09/2018 |
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 Catalogue Number | TSP |
Device Lot Number | UNK-TSP |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/09/2018
|
Initial Date FDA Received | 02/02/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|