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 2018-09-13 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Iantech, Inc..
[120241127]
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 reported problem could not be reproduced and the cause of the event remains undetermined. 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 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
[120241128]
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 loop was partially deployed when the remainder of the loop deployed unexpectedly. The surgeon retracted and redeployed the loop ensuring the entire loop was under the capsulorhexis. The loop was then rotated past the midline, returned to midline and bisected and the distal nucleus prolapsed slightly. A second instrument was used to free the loop and rotate the nucleus. The surgeon noticed that the distal nucleus was still tilted up and the proximal still down in the bag and the nucleus was moving around too much and a decision was made to remove the miloop from the eye, at which time clear fluid (believed to be vitreous fluid) was observed on the loop. The surgeon proceeded with phacoemulsification and 2/3 of way through the procedure there was vitreous loss (from a posterior capsular bag tear) and a lens fragment dislocated into the vitreous. A vitrectomy was performed and an anterior chamber intraocular lens was implanted and the incision was sutured. The patient was referred to a retina specialist for retrieval of the dropped nuclear fragment. Additional information is being requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00007 |
| MDR Report Key | 7875286 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-13 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-11-20 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2018-09-13 |
| 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 | 2018-09-13 |
| Returned To Mfg | 2018-08-20 |
| Model Number | FG-11881 |
| Lot Number | FG20180326-01 |
| Device Expiration Date | 2019-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-09-13 |