MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-19 for LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881 manufactured by Iantech, Inc..
[95322614]
The device was discarded by the user and is not available for evaluation. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. The event was attributed to patient movement during the procedure and there was no report of a device malfunction. Capsular bag damage and vitreous loss is an inherent risk of cataract surgery. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95322615]
A patient underwent cataract surgery in the right eye on (b)(6) 2017 where the leep device was used to section the cataractous lens into fragments. During surgery, a femtosecond laser was used for nucleus fragmentation, after which the leep device was introduced into the eye. While the leep was in the eye and prior to making the first retraction, the patient raised her head unexpectedly. There were no other device in the eye at the time of patient movement. The leep was retracted from the eye and the surgeon proceeded with lens removal. When the first quadrant was removed it was discovered that the posterior capsule had torn and vitreous fluid was present. A vitrectomy was performed and the intraocular lens was implanted without incident. Postoperatively the patient is stable and there is no adverse impact on the patient's vision and no sequelae. The surgeon attributed the capsular tear to patient movement during closure of the leep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2017-00004 |
| MDR Report Key | 7130883 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-08-07 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2017-06-05 |
| Date Added to Maude | 2017-12-19 |
| 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 | 3 |
| Manufacturer Contact | JANE DEMKOVICH |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal | 89521 |
| Manufacturer Phone | 7754731014 |
| Manufacturer G1 | IANTECH, INC. |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 89521 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2017-12-19 |
| Model Number | FG-11881 |
| Lot Number | FG20170605-01 |
| Device Expiration Date | 2017-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IANTECH, INC. |
| Manufacturer Address | 8748 TECHNOLOGY WAY RENO NV 89521 US 89521 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-19 |