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 foreign,health professional,u report with the FDA on 2018-02-07 for IDESIGN AWS SYSTEM 0110-0001 manufactured by Abbott Medical Optics.

Event Text Entries

[99295443] (b)(4). Fse on site completed the following: viewed all technicians that utilized the idesign during the capture sequence. Completed idesign clinical optimization checklist. Asm discussed outcomes with the tlc account regional director, clinic director and the physician. It was found that found that physician planned all treatments and the nomogram used was gleaned from a different tlc site in (b)(6). Two other physicians mentioned that the physician reporting the issues comes in (to the center) and steps into the footpedal. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[99295444] The clinic reported that photorefractive keratectomy patient had surgery on (b)(6) 2017 and presented on 1 month post-op with an astigmatism in the left eye. It was stated that the patient had a loss of best corrected visual acuity (bcva). Bcva: left eye pre-op 20/20 -4. 75 x -2. 00 x 19. Bcva 1 month post-op: left eye post-op 20/30 1. 50 x -. 50 x 130. This report is for the idesign aberrometer. A separate report is being submitted for the excimer laser.
Patient Sequence No: 1, Text Type: D, B5


[111214848] Correction: initially reported device manufacturing date from 11/1/2016 to corrected device manufacturing date august 2016. Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed. The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend. The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation. There was no product deficiency identified. The review of the device history record (dhr) the refractive idesign showed that there were no issues or non-conformities. Manufacturing has been ruled out as a potential cause for the reported issue. No conclusive evidence identified for reported issue. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006695864-2018-00234
MDR Report Key7250334
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-02-07
Date of Report2018-03-09
Date of Event2017-08-30
Date Mfgr Received2018-02-12
Device Manufacturer Date2016-11-01
Date Added to Maude2018-02-07
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 ContactVALERIE SEDZICKI
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478567
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 Received2018-02-07
Model Number0110-0001
ID NumberNI
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 2018-02-07

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