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 2017-11-27 for LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881 manufactured by Iantech, Inc..
[93030233]
The device was discarded by the user and is not available for evaluation. The event was solely attributed to use error and there was no device malfunction. Capsular bag damage is an inherent risk of cataract surgery. The device history records were reviewed for this lot number and there were no discrepancies or unusual findings that relate to the reported event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93030234]
A patient with a moderately advanced senile cataract underwent cataract surgery in the left eye on (b)(6) 2017 where the leep device was used to section the cataractous lens into fragments. During surgery, a femtosecond laser was used for the capsulotomy and nucleus fragmentation, after which the leep device was introduced into the eye and nucleus engagement was initiated. During this portion of the procedure the iris constricted causing extremely limited visibility and there was a substantial amount of proximal-distal motion during retraction of the cutting loop and removal. At some point during the phacoemulsification procedure and phaco tip chopping it was observed that the posterior capsule had ruptured. The event required secondary surgical intervention to perform an anterior vitrectomy and remove the lens fragments from the anterior chamber. A three-piece intraocular lens was implanted without incident. There was no adverse impact on the patient's vision and no sequelae. The surgeon was unable to attribute the capsular damage to one specific device and stated that use of any of the concurrent devices (femtosecond laser, phacoemulsification equipment, or the leep) may have caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123033-2017-00002 |
| MDR Report Key | 7062209 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-10-11 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2017-11-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2017-11-27 |
| Model Number | FG-11881 |
| Lot Number | FG20170828-01 |
| Device Expiration Date | 2018-08-31 |
| 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 | 2017-11-27 |