Brand Name | SOFLEX THREE-PIECE FOLDABLE LENS |
Type of Device | INTRA OCULAR LENS |
Baseline Brand Name | SOFLEX SILICONE FOLDABLE THREE-PIECE IOL |
Baseline Generic Name | LENS, INTRAOCULAR |
Baseline Catalogue Number | LI61U |
Baseline Device Family | P910061 |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | P910061 |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 09/02/1994 |
Manufacturer (Section F) |
BAUSCH & LOMB SURGICAL |
21 park place blvd., north |
clearwater FL 33759 |
|
Manufacturer (Section D) |
BAUSCH & LOMB SURGICAL |
21 park place blvd., north |
clearwater FL 33759 |
|
Manufacturer Contact |
christine
posin
|
555 w. arrow highway |
claremont
, CA 91711 |
(909)
399
-1600
|
|
Device Event Key | 288208 |
MDR Report Key | 297749 |
Event Key | 279659 |
Report Number | 6000107-2000-00020 |
Device Sequence Number | 1 |
Product Code | HQL |
Report Source |
Manufacturer
|
Source Type |
Health Professional
|
Reporter Occupation |
Physician
|
Remedial Action |
Recall
|
Type of Report
| Initial |
Report Date |
08/21/2000 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 09/20/2000 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 03/01/2004 |
Device Catalogue Number | LI61U |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 08/21/2000 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 03/01/1999 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Invalid Data
|