Brand Name | MONARCH IOL DELIVERY SYSTEM - CARTRIDGE |
Type of Device | LENS GUIDE |
Baseline Brand Name | MONARCH II IOL DELIVERY SYSTEM/CARTRIDGE |
Baseline Generic Name | LENS GUIDE, INTRAOCULAR |
Baseline Catalogue Number | 8065977758 |
Baseline Device Family | LENS GUIDE, INTRAOCULAR |
Baseline Device 510(K) Number | K981571 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 07/09/1998 |
Manufacturer (Section F) |
ALCON LABORATORIES, INC./HUNTINGTON |
6065 kyle ln |
huntington WV 25702 |
|
Manufacturer (Section D) |
ALCON LABORATORIES, INC./HUNTINGTON |
6065 kyle ln |
huntington WV 25702 |
|
Manufacturer Contact |
sherri
lakota
|
6201 south freeway |
fort worth
, TX 76134-2099 |
(817)
568
-6179
|
|
Device Event Key | 309913 |
MDR Report Key | 320386 |
Event Key | 301319 |
Report Number | 1119421-2001-00281 |
Device Sequence Number | 1 |
Product Code | KYB |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User facility
|
Reporter Occupation |
Physician
|
Remedial Action |
Other
|
Type of Report
| Initial |
Report Date |
02/07/2001 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 03/09/2001 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 8065977758 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Device Age | unknown |
Event Location |
AMBULATORY SURGICAL Facility
|
Date Manufacturer Received | 02/07/2001 |
Was Device Evaluated By Manufacturer? |
Yes
|
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
|
|