Brand Name | CIBA VISION CV232 SRE |
Type of Device | INTRAOCULAR LENS |
Baseline Brand Name | CIBA VISION MEMORYLENS |
Baseline Generic Name | INTRAOCULAR LENS |
Baseline Catalogue Number | U940A |
Baseline Model Number | U940A |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
CIBA VISION CORP. |
el jibaro industrial park |
lot#2, po 1358 |
cidra PR 00739 |
|
Manufacturer (Section D) |
CIBA VISION CORP. |
el jibaro industrial park |
lot#2, po 1358 |
cidra PR 00739 |
|
Manufacturer (Section G) |
CIBA VISION CORP |
el jibaro industrial park |
lot #2, po 1358 |
cidra PR 00739 |
|
Manufacturer Contact |
pat
strahl
|
11460 johns creek pkwy |
duluth
, GA 30097 |
(678)
415
-3816
|
|
Device Event Key | 512821 |
MDR Report Key | 523693 |
Event Key | 497068 |
Report Number | 2648694-2004-00032 |
Device Sequence Number | 1 |
Product Code | HQL |
Report Source |
Manufacturer
|
Source Type |
Health Professional
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/08/2004 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 05/05/2004 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 09/30/2000 |
Device MODEL Number | U940A |
Device Catalogue Number | U940A |
Device LOT Number | M431149 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/08/2004 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 09/01/1999 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 05/05/2004 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1,NONE REPORTED., |
|
|
|