MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS IDESIGN AWS SYSTEM; REFRACTIVE MEASUREMENT

Model Number	0110-2261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Applications support specialist verified the calibration of the idesign and looked at the fixation target and verified it.Everything was within specifications and the fixation target looked good.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Surgeon reported patient had original procedure on (b)(6) 2016.Patient programmed treatment was right -5.75 -0.25 x 005 and left -5.25 -0.25 x 154.Patient post op was: 1 month: right 1.00 -0.50 66 uncorrected 20/70 best corrected 20/30; left 1.25 -1.25 170 uncorrected 20/70 best corrected 20/25.Three months: right 2.50 -0.75 165 uncorrected 20/50 best corrected 20/20; left 2.75 -2.75 17 uncorrected 20/40 best corrected 20/20.Surgeon did enhancement on (b)(6) 2016.The current prescription is: right +1.75 -1.00 x 005; left +0.75 -2.75 x 175.There is no loss of best corrected visual acuity.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5919675
• Report Number: 3006695864-2016-00813
• Device Sequence Number: 599656
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K000327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR