Brand Name | 1-DAY ACUVUE MOIST FOR ASTIGMATISM |
Type of Device | LENSES, SOFT CONTACT, DAILY WEAR |
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 | 9468066 |
MDR Text Key | 187536986 |
Report Number | 9617710-2019-00051 |
Device Sequence Number | 1 |
Product Code |
LPL
|
Combination Product (y/n) | Y |
Reporter Country Code | SP |
PMA/PMN Number | N18033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/22/2019 |
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 | 01/01/2024 |
Device Catalogue Number | 1MA |
Device Lot Number | 3136970101 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/22/2019 |
Initial Date FDA Received | 12/13/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/13/2019 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 16 |