Brand Name | CIBA VISION MEMORY LENS |
Type of Device | INTRAOCULAR LENS |
Baseline Brand Name | CIBA VISION MEMORY LENS |
Baseline Generic Name | INTRAOCULAR LENS |
Baseline Catalogue Number | CV232 SRE |
Baseline Model Number | CV232 SRE |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
CIBA VISION CORP. |
lot #2, po 1358 |
el jibaro industrial park |
cidra PR 00739 |
|
Manufacturer (Section D) |
CIBA VISION CORP. |
lot #2, po 1358 |
el jibaro industrial park |
cidra PR 00739 |
|
Manufacturer Contact |
pat
strahl
|
11460 johns creek parkway |
duluth
, GA 30097 |
(678)
415
-3816
|
|
Device Event Key | 442225 |
MDR Report Key | 453227 |
Event Key | 429249 |
Report Number | 2648694-2003-00040 |
Device Sequence Number | 1 |
Product Code | HQL |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional
|
Reporter Occupation |
Physician
|
Remedial Action |
Other
|
Type of Report
| Initial |
Report Date |
03/13/2003 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/11/2003 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device MODEL Number | CV232 SRE |
Device Catalogue Number | CV232 SRE |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/13/2003 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 04/11/2003 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1,NONE REPORTED., |
|
|
|