MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for ACCUTOME AH7100T manufactured by Accutome Inc..
[83605685]
During cataract surgery, during phaco emulsification, the surgeon was using the wand as a second instrument and the ball/tip fell off the wand. The patient did not have an intact "wall", and the ball fell into the vitreous cavity and is still there. The surgeon left the ball from the wand in the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2521877-2017-00003 |
| MDR Report Key | 6819110 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CLAUDIA HILL |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6108890200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCUTOME |
| Generic Name | CONNOR WAND .5MM BALL SHAPED TIP, TITANIUM |
| Product Code | HND |
| Date Received | 2017-08-24 |
| Model Number | AH7100T |
| Catalog Number | AH7100T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUTOME INC. |
| Manufacturer Address | 3222 PHOENIXVILLE PIKE MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-24 |