|
|
| Model Number LI 61 U |
| Device Problem
Lens implant
|
| Event Date 08/29/2000 |
|
Patient Outcome
Required Intervention;
|
|
Event Description
|
Endophthalmitis os.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | BAUSCH & LOMB SURGICAL |
|---|
| Type of Device | INTRAOCULAR LENS |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| BAUSCH & LOMB SURGICAL |
| 555 west arrow hwy |
| clairemont CA 91711 |
|
| Manufacturer (Section D) |
| BAUSCH & LOMB SURGICAL |
| 555 west arrow hwy |
| clairemont CA 91711 |
|
| Device Event Key | 285300 |
|---|
| MDR Report Key | 294763 |
|---|
| Event Key | 276809 |
|---|
| Report Number | 294763 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | HQL |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
Physician
|
| Type of Report
| Initial |
|---|
| Report Date |
09/01/2000 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 09/01/2000 |
|---|
| Is This An Adverse Event Report? |
Yes
|
|---|
| Is This A Product Problem Report? |
No
|
|---|
| Device Operator |
Health Professional
|
| Device MODEL Number | LI 61 U |
|---|
| Was Device Available For Evaluation? |
No
|
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Date Report Sent to FDA | 09/01/2000 |
|---|
| Distributor Facility Aware Date | 09/01/2000 |
|---|
| Event Location |
AMBULATORY SURGICAL Facility
|
| Date Report TO Manufacturer | 09/01/2000 |
|---|
| Is the Device an Implant? |
Yes
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on February 28, 2009
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