Brand Name | HYDROVIEW INTRAOCULAR LENS |
Type of Device | INTRAOCULAR LENS |
Baseline Brand Name | HYDROVIEW INTRAOCULAR LENS |
Baseline Generic Name | POSTERIOR CHAMBER IOL |
Baseline Catalogue Number | H60M |
Baseline Model Number | H60M |
Other Baseline ID Number | YC |
Baseline Device Family | HYDROVIEW POSTERIOR CHAMBER INTRAOCULAR LENS |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | P990014 |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 24 |
Date First Marketed | 09/30/1995 |
Manufacturer (Section F) |
BAUSCH & LOMB SURGICAL, INC. |
21 park place blvd., north |
clearwater FL 33759 |
|
Manufacturer (Section D) |
BAUSCH & LOMB SURGICAL, INC. |
21 park place blvd., north |
clearwater FL 33759 |
|
Manufacturer Contact |
christine
posin
|
21 park place blvd., n. |
clearwater
, CA 33759 |
(727)
724
-6661
|
|
Device Event Key | 283509 |
MDR Report Key | 292909 |
Event Key | 275015 |
Report Number | 1119279-2000-00210 |
Device Sequence Number | 1 |
Product Code | HQL |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional
|
Reporter Occupation |
Physician
|
Remedial Action |
Other
|
Type of Report
| Initial |
Report Date |
07/25/2000 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 08/24/2000 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 05/01/2000 |
Device MODEL Number | H60M |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/25/2000 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 05/01/1995 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|