Brand Name | UNFOLDER PLATINUM 1 SERIES |
Type of Device | LENS, GUIDE, INTRAOCULAR |
Manufacturer (Section D) |
JOHNSON & JOHNSON SURGICAL VISION, INC. |
1700 e. st. andrew place |
santa ana CA 92705 |
|
MDR Report Key | 10430590 |
MDR Text Key | 203680987 |
Report Number | 10430590 |
Device Sequence Number | 1 |
Product Code |
KYB
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/01/2020,06/25/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1MTEC30 |
Device Catalogue Number | 1MTEC30 |
Device Lot Number | CE08507 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/01/2020 |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 08/20/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/20/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 25185 DA |
|
|