MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-20 for ALCON TOTAL PLUS 23 GA VITRECTOMY PAK 8065750828 manufactured by Alcon Laboratories, Inc..
[18910711]
During a pars plana vitrectomy for repair of a rhegmatogenous retinal attachment, it was noted that the vitrectomy probe became fused to the trocar through which it is placed into the eye. Attempted removal of the probe form the trocar resulted in the outer plastic portion of the trocar separating from the inner metal portion through which the probe is placed. The vitrector was activated to clear the port and then the probe/trocar complex was removed from the eye. Inspection of the retina noted a giant retinal tear, presumably due to vitreous incarceration between the probe and trocar. Dr considers this event to be serious and to have potential to harm pts. The tear was repaired to avoid permanent harm with recovery to be assessed at 12 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012491 |
| MDR Report Key | 1445404 |
| Date Received | 2009-08-20 |
| Date of Report | 2009-07-31 |
| Date of Event | 2009-07-29 |
| Date Added to Maude | 2009-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON TOTAL PLUS 23 GA VITRECTOMY PAK |
| Generic Name | VITRECTOMY PAK |
| Product Code | MSR |
| Date Received | 2009-08-20 |
| Catalog Number | 8065750828 |
| Lot Number | BOX NOT SAVED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134200 US 76134 2009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-20 |