ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM AU00T0 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM AU00T0 NA manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[185897398] The product was returned for analysis. 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. Results from the product history record review indicated the product met release criteria. There has been one other complaints reported in the lot number. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185897399] An inventory specialist reported that during an intraocular lens (iol) implant procedure, during advancement of the lens, there was an unfolding issue. The procedure was completed with a new lens. An enlarged incision was required during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00574
MDR Report Key9908351
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-04-18
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-01-25
Date Added to Maude2020-03-31
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 - HUNTINGTON
Manufacturer Street6065 KYLE LANE
Manufacturer CityHUNTINGTON WV 25702
Manufacturer CountryUS
Manufacturer Postal Code25702
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
Generic NameLENS, GUIDE, INTRAOCULAR
Product CodeKYB
Date Received2020-03-31
Returned To Mfg2020-03-12
Model NumberAU00T0
Catalog NumberNA
Lot Number12591406
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - HUNTINGTON
Manufacturer Address6065 KYLE LANE HUNTINGTON WV 25702 US 25702


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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