ACRYSOF IQ NATURAL SINGLEPIECE IOL SN60WF SN60WF.180

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 2020-03-30 for ACRYSOF IQ NATURAL SINGLEPIECE IOL SN60WF SN60WF.180 manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[186579017] Evaluation summary: 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


[186579018] A customer reported an intraocular lens (iol) had a severed haptic. The lens was implanted and removed during the initial procedure. An enlarged incision was required. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2020-00546
MDR Report Key9901379
Report SourceOTHER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-01-22
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-04-01
Date Added to Maude2020-03-30
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. 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 NATURAL SINGLEPIECE IOL
Generic NameINTRAOCULAR LENS
Product CodeHQL
Date Received2020-03-30
Returned To Mfg2020-03-12
Model NumberSN60WF
Catalog NumberSN60WF.180
Lot Number12698511
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - HUNTINGTON
Manufacturer Address6065 KYLE LANE HUNTINGTON WV 25702 US 25702


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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