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 2018-09-05 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Iantech, Inc..
[119151362]
The device was returned to iantech, decontaminated, and subjected to visual inspection and mechanical functional testing. The visual inspection revealed no damage and the device performed as expected. The cause of the event remains undetermined, but the surgeon suspects that patient anatomy (possible adhesion) may have been a contributing factor. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. There was no report of a device malfunction and the evaluation findings revealed no device defect. Capsular bag damage is an inherent risk of cataract surgery. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119151363]
A patient underwent cataract surgery in the left eye on (b)(6) 2018 where the miloop device was used to section the cataractous lens into fragments. During the procedure the surgeon was unable to rotate the loop around the nucleus. The surgeon retracted the loop and cut off a lens portion from the side then proceeded to the phacoemulsification portion of the procedure. The surgeon noted that the capsular bag was floppy and after phacoemulsification the surgeon observed a diagonal posterior capsular tear, but there was no vitreous loss. A three-piece intraocular lens was implanted without incident. The surgeon suspects there may have been an adhesion that caught the loop and pulled the bag, possibly precipitating the capsular tear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00004 |
| MDR Report Key | 7845090 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2018-09-05 |
| 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 | 2018-09-05 |
| Returned To Mfg | 2018-08-15 |
| Model Number | FG-11881 |
| Lot Number | FG20180326-01 |
| Device Expiration Date | 2019-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-05 |