Brand Name | PLATINUM 1 SERIES |
Type of Device | SURGICAL ADJUNCTS |
Manufacturer (Section D) |
ABBOTT MEDICAL OPTICS |
santa ana CA |
|
Manufacturer (Section G) |
ABBOTT MEDICAL OPTICS INC. |
road 402 north, km 4.2 |
anasco industrial park, pob 14 |
anasco PR 00610 |
|
Manufacturer Contact |
pam
mcclain
|
1700 east st. andrew place |
santa ana, CA 92705
|
7142478243
|
|
MDR Report Key | 6408574 |
MDR Text Key | 70065845 |
Report Number | 2648035-2017-00501 |
Device Sequence Number | 1 |
Product Code |
KYB
|
UDI-Device Identifier | 05050474540323 |
UDI-Public | (01)05050474540323(17)171227(10)CB43262 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081545 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/12/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 12/27/2017 |
Device Model Number | 1MTEC30 |
Device Catalogue Number | 1MTEC30 |
Device Lot Number | CB43262 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/16/2017 |
Initial Date FDA Received | 03/16/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/12/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/27/2016 |
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 |
Treatment | ZCB00 LENS, SERIAL NUMBER (B)(4) |
|
|