Brand Name | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE |
Type of Device | AID, SURGICAL, VISCOELASTIC |
Manufacturer (Section D) |
ALCON - COUVREUR N.V./ALCON - BELGIUM |
rijksweg 14 |
puurs B-287 0 |
BE B-2870 |
|
MDR Report Key | 7568561 |
MDR Text Key | 110045132 |
Report Number | 3002037047-2018-00010 |
Device Sequence Number | 1 |
Product Code |
LZP
|
Combination Product (y/n) | N |
PMA/PMN Number | P890047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
08/31/2018 |
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 |
Physician
|
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/10/2018 |
Initial Date FDA Received | 06/05/2018 |
Supplement Dates Manufacturer Received | 08/06/2018
|
Supplement Dates FDA Received | 08/31/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | CUSTOM PAK; UNSPECIFIED VISCOELASTIC; CUSTOM PAK; UNSPECIFIED VISCOELASTIC |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|