Brand Name | TECNIS |
Type of Device | MONOFOCAL IOLS |
Manufacturer (Section D) |
JOHNSON AND JOHNSON SURGICAL VISION, INC. |
santa ana CA |
|
Manufacturer (Section G) |
JOHNSON AND JOHNSON SURGICAL VISION, INC. |
road 402 north, km 4.2 |
anasco industrial park, pob 1408 |
anasco PR 00610 |
|
Manufacturer Contact |
pam
mcclain
|
1700 east st. andrew place |
santa ana, CA 92705
|
7142478243
|
|
MDR Report Key | 7445993 |
MDR Text Key | 106008753 |
Report Number | 2648035-2018-00559 |
Device Sequence Number | 1 |
Product Code |
HQL
|
UDI-Device Identifier | 05050474528888 |
UDI-Public | (01)05050474528888(17)180929 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P990080 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/04/2018 |
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? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 09/29/2018 |
Device Model Number | ZA9003 |
Device Catalogue Number | ZA90030135 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/30/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/20/2018
|
Initial Date FDA Received | 04/20/2018 |
Supplement Dates Manufacturer Received | 05/07/2018
|
Supplement Dates FDA Received | 06/04/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/29/2013 |
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;
|
Patient Age | 67 YR |
|
|