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 2018-06-05 for LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881 manufactured by Iantech, Inc..
[110164315]
The device was discarded by the user 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. The event was attributed to a combination of patient movement during the procedure and a very dense cataract with weak zonules, which predisposed the patient, and a lack of insurance coverage for general anesthesia which was warranted for the dense cataract. There was no report of a device malfunction. Capsular bag damage and vitreous loss are inherent risks of cataract surgery. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110164316]
A patient with a very dense cataract and weak zonules underwent cataract surgery on (b)(6) 2018 where the leep device was used to section the cataractous lens into fragments. The surgeon requested general anesthesia because of the dense cataract and anticipated procedure length, but the insurance company only covered local anesthesia. During the procedure while the surgeon was bisecting the nucleus and retracting the loop, the patient abruptly moved his head and the loop of the leep device inadvertently caught the capsulorhexis and caused a rent. The surgeon attempted to mitigate the damage, but the capsular tear extended during phacoemulsification and secondary surgical intervention was required (extracapsular cataract extraction with a vitrectomy) and a 3-piece intraocular lens was implanted. The patient's postoperative best corrected visual acuity (bcva) is 20/50.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2018-00003 |
| MDR Report Key | 7571785 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-05-13 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2018-06-05 |
| 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 | LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2018-06-05 |
| Model Number | FG-11881 |
| Lot Number | FG20171201-01 |
| Device Expiration Date | 2018-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2018-06-05 |