Brand Name | CRYSTALENS HD IOL |
Type of Device | LENS, INTRAOCULAR, ACCOMODATIVE |
Manufacturer (Section D) |
BAUSCH & LOMB, INC. |
rochester NY |
|
Manufacturer Contact |
sharon
spencer
|
50 technology drive |
irvine, CA 92618
|
9493985698
|
|
MDR Report Key | 4873897 |
MDR Text Key | 6048088 |
Report Number | 1313525-2015-01837 |
Device Sequence Number | 1 |
Product Code |
NAA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,company representati |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/26/2015 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/15/2013 |
Device Model Number | HD500 |
Device Lot Number | 015365 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/26/2015 |
Initial Date FDA Received | 06/25/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/30/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/01/2013 |
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) |
Other;
|
Patient Age | 66 YR |
|
|