MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-25 for GRAYSON NUCLEUS MANIPULATOR E0725 manufactured by Bausch & Lomb, Inc..
[538993]
In 2006, the tip of the instrument broke off during an iol implantation and was unknowingly left in the patient's eye. Six months later, the patient experienced inflammation and blurred vision and the tip was subsequently discovered and removed from the eye. There has been some corneal decompensation and the patient will be monitored for a possible corneal transplant.
Patient Sequence No: 1, Text Type: D, B5
[7797807]
The device has been requested, but has not yet been received. Should the device or additional information become available a follow-up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2006-00852 |
| MDR Report Key | 755727 |
| Report Source | 06 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-07-28 |
| Date of Event | 2006-07-27 |
| Date Mfgr Received | 2006-07-28 |
| Date Added to Maude | 2006-08-31 |
| 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 |
| 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 | GRAYSON NUCLEUS MANIPULATOR |
| Generic Name | OPHTHALMIC SPATULA |
| Product Code | HND |
| Date Received | 2006-08-25 |
| Model Number | NA |
| Catalog Number | E0725 |
| 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 | 743565 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | * ROCHESTER NY 14609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-25 |