LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for LOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE FG-11881 manufactured by Iantech, Inc..

Event Text Entries

[93035847] 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. Manufacturer's reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[93035848] A patient with a moderately advanced senile cataract underwent cataract surgery in the right 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 there was aggressive manipulation with over-rotation and extension past the midline as well as multiple sweeps during capsule polishing. 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


MAUDE Entry Details

Report Number3012123033-2017-00001
MDR Report Key7062194
Date Received2017-11-27
Date of Report2017-11-27
Date of Event2017-09-11
Date Mfgr Received2017-10-11
Device Manufacturer Date2017-08-28
Date Added to Maude2017-11-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJANE DEMKOVICH
Manufacturer Street8748 TECHNOLOGY WAY
Manufacturer CityRENO NV 89521
Manufacturer CountryUS
Manufacturer Postal89521
Manufacturer Phone7754731014
Manufacturer G1IANTECH, INC.
Manufacturer Street8748 TECHNOLOGY WAY
Manufacturer CityRENO NV 89521
Manufacturer CountryUS
Manufacturer Postal Code89521
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLOW ENERGY ENDOCAPSULAR PHACO (LEEP) DEVICE
Generic NameOPHTHALMIC HOOK
Product CodeHNQ
Date Received2017-11-27
Model NumberFG-11881
Lot NumberFG20170828-01
Device Expiration Date2018-08-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIANTECH, INC.
Manufacturer Address8748 TECHNOLOGY WAY RENO NV 89521 US 89521


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-27

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