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..
[119324277]
The device was discarded by the 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. There was no report of a device malfunction. Capsular bag damage and dropped nuclear fragments are inherent risks of cataract surgery. [reference: schaal s, nesmith blw, ihnen ma, al-latayfeh m. Current medical and surgical management of retained lens fragments after cataract extraction. Us ophthalmic review 2014;7(2):95-99. ]. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119324278]
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 used a second instrument to facilitate rotation of the lens for the second miloop cut. After the second cut was made, the capsular bag ruptured posteriorly and a lens fragment dislocated into the vitreous cavity. The patient was referred to a retina specialist for intervention to address the dropped nuclear fragment. The surgeon reports that the patient is doing well postoperatively. Additional information is being requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00006 |
| MDR Report Key | 7848850 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-05 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-10-10 |
| 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 |
| Model Number | FG-11881 |
| Lot Number | FG20180326-01 |
| Device Expiration Date | 2019-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-09-05 |