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	Corneal Clouding/Hazing (1878)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing date - not available at the time of this report.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that presented for the 3 month post op visit on (b)(6) 2017 with mild haze in both eyes.The haze was above and below the visual axes.At the 6 months post op visit on (b)(4) 2017 the haze appeared more dense but was still located only above and below the visual axix and was again not considered to be visually significant as uncorrected visual acuity was 20/16 in right eye and 2016 in left eye (20/13 both eyes).At that visit, the subject was treated with fml every 2 hours for 2 weeks.The subject was seen on the (b)(6) and placed on a 6 week fml taper on that last visit.Subject was scheduled for (b)(6) 2017 but did not attend.This report is for the idesign system.A separate report is being submitted for the visx system.
Additional Manufacturer Narrative
A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.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: 6947055
• Report Number: 3006695864-2017-00889
• Device Sequence Number: 16368572
• 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,Followup
• Report Date (Section B): 12/05/2017

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
• Device Catalogue Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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