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	Visual Impairment (2138)
Date of Event	03/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): - field service specialist visited the account and cleaned optics of balanced salt solution, which was causing an artifact.Adjusted flat to plano and adjusted the sphere.Tested system.No problems found all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that patient had lasik with idesign procedure and presented with overcorrection in right eye post treatment.Patient experienced loss of best corrected visual acuity (bcva) equal to or above 2 lines.No intervention was required.Right eye: pre-op: -6.86 -0.35 x 41 bcva 20/20, post-op: +1.75 -0.25 x 95 bcva 20/30.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6495673
• Report Number: 3006695864-2017-00230
• Device Sequence Number: 10984056
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: 03/20/2017
• Initial Report FDA Received Date: 04/14/2017
• 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
• Patient Age: 51 YR