Brand Name | CELLUGEL 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 |
|
Manufacturer (Section G) |
ALCON - COUVREUR N.V./ALCON - BELGIUM |
rijksweg 14 |
|
puurs B-287 0 |
BE
B-2870
|
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 17057367 |
MDR Text Key | 316484401 |
Report Number | 3002037047-2023-00024 |
Device Sequence Number | 1 |
Product Code |
LZP
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P990023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
08/03/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/25/2023
|
Initial Date FDA Received | 06/05/2023 |
Supplement Dates Manufacturer Received | 07/05/2023
|
Supplement Dates FDA Received | 08/03/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | ACRYSOF SINGLEPIECE IOL.; ACRYSOF SP FOLDABLE 6.0 OPTIC FX.; ALCON CELLUGEL.; HPMC 2%.; MONARCH III D CARTRIDGES.; MONARCH III IOL DELIVERY SYST.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR. |
Patient Age | 78 YR |
Patient Sex | Female |