MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-05 for WILLIAMS LACRIMAL PROBE E4210 manufactured by Bausch & Lomb, Inc..
[16110368]
The tip of the instrument broke off in the patient's eye during a procedure and could not be retrieved. A second attempt was made later in the day to remove the tip but was unsuccessful. The practive remains in the eye and the patient outcome is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2006-00035 |
| MDR Report Key | 709030 |
| Report Source | 05 |
| Date Received | 2006-05-05 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-04-10 |
| Date Mfgr Received | 2006-04-10 |
| Date Added to Maude | 2006-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANET LACAVICH, MANAGER |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263213 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLIAMS LACRIMAL PROBE |
| Generic Name | LACRIMAL PROBE |
| Product Code | HNL |
| Date Received | 2006-05-05 |
| Model Number | NA |
| Catalog Number | E4210 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 698074 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | * ROCHESTER NY 14609 US |
| Baseline Brand Name | PRB LACH 00-0 WILLIAMS |
| Baseline Generic Name | LACHRYMAL PROBE |
| Baseline Model No | NA |
| Baseline Catalog No | E4210 |
| Baseline ID | * |
| Baseline Device Family | LACHRYMAL PROBE |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-05-05 |