IDESIGN AWS SYSTEM 0110-2261

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-01 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Abbott Medical Optics.

Event Text Entries

[74144912] Date of event: best estimate date ((b)(6) 2017) is provided as the reporter has indicated the onset of symptoms occurred at one month post exam of initial procedure. The clinic is reporting this adverse event only and did not request or require field service or clinical support. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[74144913] The surgery center reported that a laser vision correction patient was presented with overcorrection. A description from the surgery center indicated the patient that had initial laser treatment performed on (b)(6) 2017. At a one month post-operative exam, the patient had sub-optical results that were overcorrections. Although, the point of refractive stability had not been reached, the surgeon made a decision to perform secondary surgery as the surgeon realized it would not stabilize. The surgery center reported that there have been no other incidents of overcorrections and believes since it was the first time using the idesign equipment; the surgeon had consulted with another surgeon who recommended the hyper focal length and optical infinity settings, although he was not comfortable changing the settings at the time, he had changed the settings. The surgeon believes changing the settings caused the overcorrections. The surgeon has reverted back to the default settings and has no issues since then. In addition, the surgery center reported 4 patients experienced overcorrections. This report is for patient #3.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006695864-2017-00268
MDR Report Key6535338
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-05-01
Date of Report2017-05-01
Date of Event2017-02-23
Date Mfgr Received2017-04-03
Device Manufacturer Date2016-12-13
Date Added to Maude2017-05-01
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. LOURDES GUEVARA
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478497
Manufacturer G1ABBOTT MEDICAL OPTICS INC.
Manufacturer Street510 COTTONWOOD DRIVE
Manufacturer CityMILPITAS CA 95035
Manufacturer CountryUS
Manufacturer Postal Code95035
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDESIGN AWS SYSTEM
Generic NameREFRACTIVE MEASUREMENT
Product CodeHKO
Date Received2017-05-01
Model Number0110-2261
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MEDICAL OPTICS
Manufacturer AddressSANTA ANA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-05-01

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