Brand Name | RAINDROP NEAR VISION INLAY |
Type of Device | CORNEAL INLAY |
Manufacturer (Section D) |
REVISION OPTICS |
25651 atlantic ocean dr., |
ste. a1 |
lake forest CA 92630 8835 |
|
Manufacturer (Section G) |
REVISION OPTICS |
25651 atlantic ocean dr., |
ste. a1 |
lake forest CA 92630 8835 |
|
Manufacturer Contact |
pushpita
singh
|
25651 atlantic ocean dr., |
ste. a1 |
lake forest, CA 92630-8835
|
9497072740
|
|
MDR Report Key | 6375176 |
MDR Text Key | 68965334 |
Report Number | 3005956347-2017-00021 |
Device Sequence Number | 1 |
Product Code |
LQE
|
UDI-Device Identifier | 10850394006013 |
UDI-Public | (01)10850394006013(17)190822(10)002984 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150034 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
01/30/2017 |
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 | 08/22/2019 |
Device Model Number | 610-0001 |
Device Lot Number | 002984 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/31/2017 |
Initial Date FDA Received | 03/02/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/22/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 3005956347-02/03/17-001 |
Patient Sequence Number | 1 |
Treatment | DUREZOL; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 58 YR |