MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-05 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Iantech, Inc..
[119325020]
The device was returned to iantech and examined upon receipt; a small bump was observed on the outside of the carton where the device appeared to have moved forward during shipment. The device was subsequently decontaminated and subjected to visual inspection, which revealed damage to the wire housing tube, which was bent out of shape (likely from impact). The damage is believed to be the result of impact sustained during transit. Review of the surgical video provided by the surgeon confirmed there was no observable device damage at the time of surgery. The condition of the returned device precluded thorough mechanical functional testing, however the device was opened and visually inspected and no anomalies were observed. Review of the surgical video (miloop excerpt provided) did not yield any root cause information and the complete surgical video was requested. The cause of the capsular tear remains unknown at this time. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event. Capsular bag damage is an inherent risk of cataract surgery. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119325021]
A patient underwent cataract surgery on (b)(6) 2018 where the miloop device was used to section the cataractous lens into fragments. During the procedure the surgeon noted some friction associated with slider actuation. Limited information was provided regarding the surgical details, however, a posterior capsule rupture occurred. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00005 |
| MDR Report Key | 7848558 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| 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 | 2018-08-10 |
| 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 |