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 2018-11-15 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Iantech, Inc..
[127256203]
The device was discarded by the user facility 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. Additional "informaiton" has been requested from the surgeon, but the preliminary information suggests the event was attributed to unexpected patient movement during the procedure. Capsular bag damage is an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127256204]
A patient underwent cataract surgery on (b)(6) 2018 where the miloop device was used to section the cataractous lens into fragments. As the surgeon was preparing to bisect the lens the patient moved unexpectedly, resulting in a posterior capsule tear. There was no vitreous loss, no vitrectomy was performed, and a 3-piece intraocular lens was implanted in the sulcus. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00009 |
| MDR Report Key | 8074090 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-04-11 |
| Date Added to Maude | 2018-11-15 |
| 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 | MILOOP LENS FRAGMENTATION DEVICE |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2018-11-15 |
| Model Number | FG-11881 |
| Lot Number | FG20180411-20 |
| Device Expiration Date | 2019-04-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-15 |