IDESIGN AWS SYSTEM 0110-0001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-06-26 for IDESIGN AWS SYSTEM 0110-0001 manufactured by Abbott Medical Optics.

Event Text Entries

[11119718] The patient was retreated for undercorrections and their uncorrected visual acuity is now 6/9 (approximately 20/30). Post op best corrected visual acuity is not available. Placeholder.
Patient Sequence No: 1, Text Type: N, H10


[11317798] Additional information received for the patient, auto refraction measurement taken on (b)(6) 2013 results: od: +0. 25s +0. 50d x 130, os: +0. 25s, bcva? 6/6p (20/20) for both od and os. After this date patient has not come back to clinic for check up. All pertinent information available to the manufacturer has been submitted placeholder.
Patient Sequence No: 1, Text Type: N, H10


[15771354] The clinic reported that a laser vision correction patient presented at a post op exam with an over corrected vision treatment in each eye. The patient's best corrected visual acuity was 6/18 (20/50).
Patient Sequence No: 1, Text Type: D, B5


[15875183] (b)(4): undercorrected vision. Device currently not marketed in the us. An amo authorized representative evaluated the system at the customer location and found that the customer had changed the lane length of the manifest refraction device (mr) but did not update the lane length in the idesign to correspond with the change. Field service corrected the settings in the idesign to match the mr. Instructions were provided to the customers by the amo clinical development manager stressing the importance of following the protocol for matching the mr with idesign scan and to use the recommended nomogram. All pertinent information available to amo has been submitted.?
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006695864-2013-00230
MDR Report Key3191320
Report Source01,05,07
Date Received2013-06-26
Date of Report2013-06-08
Date of Event2013-03-22
Date Mfgr Received2013-10-23
Device Manufacturer Date2012-10-08
Date Added to Maude2013-06-26
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 FDA0
Event Location0
Manufacturer ContactCAROL KAIL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478598
Manufacturer G1ABBOTT MEDICAL OPTICS INC.
Manufacturer StreetAMO MANUFACTURING 510 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 Received2013-06-26
Model Number0110-0001
Catalog Number0110-0001
OperatorPHYSICIAN
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MEDICAL OPTICS
Manufacturer AddressSANTA ANA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-06-26

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