MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-05 for BAUSCH AND LOMB STORZ ANTERIOR CHAMBER NEEDLE manufactured by Bausch And Lomb Storz.
[1267242]
Patient had a phacoemulsification and implantation for a 26. 0 diopter lens in the right eye for a posterior subcapsular cataract of the right eye. Following insertion of the pciol and irrigation of the wound via cannula, the physician noted questionable material in the right eye. Physician notes the questionable material to be shiny fragments. After repeated irrigation and aspirations of the wound, only 2 extremely tiny fragments were found attached to elements that could not be removed. An orbital xray of the right eye was negative. Postoperative followup finds the patient's vision to be 20/20 and fragments are no longer visible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011377 |
| MDR Report Key | 1400301 |
| Date Received | 2009-06-05 |
| Date of Report | 2009-06-05 |
| Date of Event | 2009-05-27 |
| Date Added to Maude | 2009-06-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAUSCH AND LOMB STORZ ANTERIOR CHAMBER NEEDLE |
| Generic Name | ANTERIOR CHAMBER NEEDLE |
| Product Code | HNM |
| Date Received | 2009-06-05 |
| Lot Number | E49927 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH AND LOMB STORZ |
| Manufacturer Address | 180 VERDE DRIVE SAN DIMAS CA 91773 US 91773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-05 |