Brand Name | ACRYSOF MULTIPIECE IOL |
Type of Device | INTRAOCULAR LENS |
Manufacturer (Section D) |
PT. CIBA VISION BATAM |
beringin kav. #204 batamindo |
industrial park muka kuning |
pulau batam 29433 |
ID 29433 |
|
Manufacturer (Section G) |
PT. CIBA VISION BATAM |
beringin kav. #204 batamindo |
industrial park muka kuning |
pulau batam 29433 |
ID
29433
|
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 18425993 |
MDR Text Key | 332394078 |
Report Number | 9681121-2024-00001 |
Device Sequence Number | 1 |
Product Code |
HQL
|
UDI-Device Identifier | 00380652552448 |
UDI-Public | 00380652552448 |
Combination Product (y/n) | N |
Reporter Country Code | LU |
PMA/PMN Number | P930014 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/02/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MA60AC |
Device Catalogue Number | MA60AC.160 |
Device Lot Number | 31514234 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/05/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/13/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM. |