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	Corneal Clouding/Hazing (1878); Visual Impairment (2138)
Date of Event	12/20/2016
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 oct/2015 all pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that patient had surgery on (b)(6) 2016 and presented on (b)(6) 2016 with clinically significant corneal haze in both eyes (more in left than in right side) and loss of 2 lines best spectacle corrected visual acuity in left eye.Patient was prescribed predforte 1% for both eyes every 2 hours and refresh tears every 2 hours.Patient was told to return for follow up in 10 days.Follow up occurred on (b)(6) 2016 with medical finding of mild corneal haze and reticular pattern opacification within ablation zone, somewhat less dense.Per examining doctor, responding well to the treatment.Patient to continue predforte and uv protection.Patient was told to return for follow up in 10 days.
Additional Manufacturer Narrative
In the initial mdr only the month and year of manufacture was provided.The complete manufacturing date has now been provided.10/09/2015.Additional information: account reported that patient's right eye mild haze is not affecting refraction, the left eye moderate haze refraction was possible.Also the relatively clear zones/ patches between reticular pattern opacification appear increasingly clear in both eyes.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6258924
• Report Number: 3006695864-2017-00036
• Device Sequence Number: 1027181
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/08/2017

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): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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: Required Intervention