MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-11-28 for EYE SPHERE 20MM L1420 manufactured by Bausch & Lomb, Inc..
| Report Number | 1920664-2001-00041 |
| MDR Report Key | 364208 |
| Report Source | 06 |
| Date Received | 2001-11-28 |
| Date of Event | 2001-10-19 |
| Date Mfgr Received | 2001-10-29 |
| Date Added to Maude | 2001-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULI MOORE |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE SPHERE 20MM |
| Generic Name | EYE SPHERE IMPLANT |
| Product Code | HPZ |
| Date Received | 2001-11-28 |
| Model Number | NA |
| Catalog Number | L1420 |
| Lot Number | S2297 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 353305 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 21 PARK PLACE BLVD NORTH CLEARWATER FL 33759 US |
| Baseline Brand Name | EYE SPHERE 20MM |
| Baseline Generic Name | EYE SPHERE IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | L1420 |
| Baseline ID | NA |
| Baseline Device Family | IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 61 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921106 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-28 |