Brand Name | ACUVUE® VITA¿ FOR ASTIGMATISM |
Type of Device | LENSES, SOFT CONTACT, DAILY WEAR |
Manufacturer (Section D) |
JOHNSON & JOHNSON VISION CARE, INC. - US |
7500 centurion parkway |
jacksonville FL 32256 |
|
Manufacturer Contact |
richard
holmes
|
7500 centurion parkway |
jacksonville, FL 32256
|
9548020487
|
|
MDR Report Key | 12782833 |
MDR Text Key | 282126096 |
Report Number | 1057985-2021-00170 |
Device Sequence Number | 1 |
Product Code |
LPL
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K160212 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/09/2021 |
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 | 08/01/2022 |
Device Catalogue Number | AAS |
Device Lot Number | B00NXHM |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/18/2021 |
Initial Date FDA Received | 11/09/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/21/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
Other;
|