MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for ICON, USA manufactured by .
[63191243]
During a cataract extraction the "chopper" instrument tip broke off in pt's eye. Dr did visual inspection, removed the "tip" that had broken off. The eye was x-rayed for any retained material. X-ray shared no retained material in eye. Purchased prior to icon, usa - 1990.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066865 |
| MDR Report Key | 6199319 |
| Date Received | 2016-12-20 |
| Date of Report | 2016-10-24 |
| Date of Event | 2016-10-24 |
| Date Added to Maude | 2016-12-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ICON, USA |
| Generic Name | LENS HOOK, BLUNT TIP ANGLED 45 DEGREES "CHOPPER" |
| Product Code | HNQ |
| Date Received | 2016-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-20 |