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 2018-03-06 for LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881 manufactured by Iantech, Inc..
[101578852]
The device was discarded by the user and is not available for evaluation. The device history records were reviewed for this lot and there were no discrepancies or unusual findings that relate to the reported event. The surgeon attributed the event to part of the learning curve for a new device. There was no report of a device malfunction. Capsular bag damage and vitreous loss are inherent risks of cataract surgery. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101578853]
A patient underwent cataract surgery on (b)(6) 2017 where the leep device was used to section the cataractous lens into fragments. During the procedure the posterior capsule tore and resulted in a loss of vitreous fluid. The event required secondary surgical intervention to address the vitreous loss and perform deferred intraocular lens implantation with an anterior chamber lens. The patient's postoperative visual acuity is 20/20. The surgeon attributed the event to the learning curve with a new device. Additional information is being requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00002 |
| MDR Report Key | 7315967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2018-02-05 |
| Device Manufacturer Date | 2017-09-19 |
| Date Added to Maude | 2018-03-06 |
| 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 | 2018-03-06 |
| Model Number | FG-11881 |
| Lot Number | FG20170919-01 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2018-03-06 |