CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE

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 2020-03-27 for CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE manufactured by Alcon Research, Llc - Irvine Technology Center.

Event Text Entries

[186755648] 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186755649] A physician reported three patient's experienced a rhexis break capsular rupture following a software update on the system. The surgeon noted that the ultrasounds were too "effective". This file represents the second of four patients. Additional information has been requested but not received. A completed questionnaire form the surgeon has been received. The cataract was a 4+ soft cortico-nuclear. The surgeon noted an occlusion during the procedure. Aspiration was too strong at the start of phacoemulsification chop. There was a rupture of anterior capsule. (rhexis) at 5 o? Clock position as soon as introduction of the handpiece. There was a problem positioning the toric intraocular lens (iol) because of the placement axis. The iol was placed in the capsule bag. The patient's symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028159-2020-00283
MDR Report Key9888014
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-01-13
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
Manufacturer G1ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
Generic NameUNIT, PHACOFRAGMENTATION
Product CodeHQC
Date Received2020-03-27
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-27

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