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	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.No patient code available for overcorrection.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.
Event or Problem Description
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 #1.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6535238
• Report Number: 3006695864-2017-00266
• Device Sequence Number: 11079310
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/01/2017

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: 04/03/2017
• Initial Report FDA Received Date: 05/01/2017
• 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: 42 YR