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 2018-10-02 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Iantech, Inc..
[122372207]
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; however, the surgeon believes the miloop pierced the posterior capsule (presumably during patient movement). 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. ] manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122372208]
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 patient unexpectedly moved his eye upwards; the surgeon moved along with the patient to keep the cannula centered, then rotated the miloop and bisected the lens. The patient then returned his eye to a neutral position and the surgeon redeployed the miloop. A second instrument was used to rotate the nucleus within the loop and the lens was bisected and the miloop was removed from the eye. The surgeon proceeded with phacoemulsification and suspected a capsule tear because the lens segments were not coming up to the phaco tip as expected, and the surgeon used a second instrument to aid in retrieving the lens segments. Once the nucleus was removed a tear was observed in the posterior capsule, there was vitreous loss, and a small lens fragment dislocated into the vitreous. A vitrectomy was performed, the lens fragment was removed from the vitreous, and an anterior chamber intraocular lens was implanted. Follow-up was requested and the surgeon provided the following additional information. The patient was referred to a retinal specialist and is currently under observation. The event resulted in uveitis and glaucoma (note: the patient had a history of glaucoma). The patient's best corrected visual acuity (bcva) decreased from 20/70 preoperatively to counting fingers (cf) 2 weeks postoperatively and the patient's prognosis is guarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00008 |
| MDR Report Key | 7926857 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| Returned To Mfg | 2018-09-19 |
| Model Number | FG-11881 |
| Lot Number | FG20180328-20 |
| Device Expiration Date | 2019-03-27 |
| 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 | 2018-10-02 |