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 Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	12/30/2015
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) 2015.Patient post op was: one month: right 3.25 -0.50 61 uncorrected 20/20; left 3.00 -0.50 14 uncorrected 20/25.Three months: right 3.50 -0.75 95 best corrected 20/15; left 3.75 -0.75 120 best corrected 20/15.Surgeon did enhancement at 3 months.Prescription 3 months post enhancement: right uncorrected 20/20.Left 2.25 -1.50 x 20 uncorrected is 20/30 and best corrected is 20/30+.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5919546
• Report Number: 3006695864-2016-00810
• Device Sequence Number: 16413405
• 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: Health Professional
• 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: 38 YR