ACRYSOF MULTIPIECE IOL MA60AC MA60AC.185

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-05-30 for ACRYSOF MULTIPIECE IOL MA60AC MA60AC.185 manufactured by Alcon Research, Llc - Huntington.

Event Text Entries

[146499655] Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. Root cause has not been identified. There has been two other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[146499656] A facility representative reported that during an intraocular lens (iol) implant procedure, the surgeon noted the lens was very stiff and was unable to manipulate into the cartridge or fold the lens with folding forceps. An enlarged incision was required to complete the procedure. The sample is available for return.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119421-2019-00791
MDR Report Key8653944
Report SourceFOREIGN,USER FACILITY
Date Received2019-05-30
Date of Report2019-09-11
Date of Event2019-05-02
Date Mfgr Received2019-08-18
Device Manufacturer Date2015-09-09
Date Added to Maude2019-05-30
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
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 MULTIPIECE IOL
Generic NameINTRAOCULAR LENS
Product CodeHQL
Date Received2019-05-30
Returned To Mfg2019-07-20
Model NumberMA60AC
Catalog NumberMA60AC.185
Lot Number12399173
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-05-30

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