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	Erosion (1750); Edema (1820)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinic is reporting this adverse event only and did not request or require field service or clinical support.Manufacturing date requested but not available at the time of this report.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Surgeon reported that a laser vision correction patient had surgery and presented on (b)(6) 2016 with recurrent corneal erosion with surrounding brawny edema in left eye.It was reported that patient is being follow up and scheduled to be seen the next day, (b)(6).The site notified that the patient did not show for the (b)(6) appointment however was seen on (b)(6) 2017 and according to the medical record the doctor noted adverse event resolved.The resolution date is therefore (b)(6) 2017.
Additional Manufacturer Narrative
It was reported that patient had surgery on (b)(6) 2016.Manufacturing date provided 11/19/2015.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6250952
• Report Number: 3006695864-2017-00029
• Device Sequence Number: 16332616
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017

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: Health Professional
• Device Model Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCIMER SN (B)(4)
• Outcome Attributed to Adverse Event: Other