MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS IDESIGN AWS SYSTEM; REFRACTIVE MEASUREMENT

Model Number 0110-2261

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Edema (1820)

Event Date 12/19/2016

Event Type  Injury  

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 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.

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
• Type of Device: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 6250952
• MDR Text Key: 64791242
• Report Number: 3006695864-2017-00029
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: EXCIMER SN (B)(4)
• Patient Outcome(s): Other