INTREPID AUTOSERT IOL HANDPIECE 8065751755

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-30 for INTREPID AUTOSERT IOL HANDPIECE 8065751755 manufactured by Alcon Research, Ltd. - Irvine Technology Center.

Event Text Entries

[103965319] Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[103965320] A customer reported that during a cataract procedure, the intraocular lens implant (iol) shot out of the lens injector and damaged the capsular bag, in the left eye. The iol was removed from the eye and a different model iol was inserted outside the capsular bag. Subconjunctival steroids and topical glaucoma medications were given. Several days later, the patient underwent a vitrectomy procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2018-00654
MDR Report Key7385362
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-30
Date of Report2018-07-30
Date of Event2018-03-01
Date Mfgr Received2018-07-18
Date Added to Maude2018-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRYAN BLAKE
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152230
Manufacturer G1ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameINTREPID AUTOSERT IOL HANDPIECE
Generic NameAPPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
Product CodeHQR
Date Received2018-03-30
Model NumberNA
Catalog Number8065751755
Lot NumberNA
ID Number380657517558
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.