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	12/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Field service specialist (fss) visited the account and found no problems with the system as it met abbott¿s specifications.As a proactive measure fss replaced the aberrometer and transferred customers database over to the new computer and gave the customer the hard drives out of other computer.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The clinic reported that a laser vision correction patient had photorefractive keratectomy surgery on (b)(6) 2015 and presented at the 6 months post treatment visit with overcorrection in right eye.It was stated that the patient had no loss of best corrected visual acuity (bcva).Patient manifest refraction at the 6 months follow up visit for right eye was 2.25 x 0.75 x 125.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6045926
• Report Number: 3006695864-2016-00886
• Device Sequence Number: 13516687
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: 09/24/2016
• Initial Report FDA Received Date: 10/20/2016
• 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 LASER SN (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR