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 Ulcer (1796); Unspecified Infection (1930); Discomfort (2330)
Date of Event	12/07/2016
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.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Patient had photorefractive keratectomy in both eyes 7 months ago and reported that he had several episodes where he has awoken in the morning with the sensation that his eyelids were stuck to his eyes.He reported that the experience gives him mild discomfort but is symptom free by mid morning.He presented because he said that 48 hours ago he awoke with discomfort and redness that did not improve and requested further evaluation.He was found with corneal ulcer in right eye: likely recurrent corneal erosion with secondary infection.He was also found to have a corneal infiltrate without epithelial defect and was started on hourly vigamox following an every 15 minute loading dose.Patient was seen next day and stated feeling slightly better than yesterday with mild discomfort, watering and not light sensitive.The central infiltrate is noted to be slightly larger diameter, nasally than yesterday.Patient was prescribed vancomycin every hour, doxycycline 100mg daily, bacitracin at bedtime and moxifloxacin every hour.Patient was seen on (b)(6) then again on (b)(6).Patient is getting better however not resolved.Surgeon noted in medical examination ¿bland opacity; no epi defect.No brawny edema.¿.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6220534
• Report Number: 3006695864-2017-00001
• Device Sequence Number: 279976
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/03/2017

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: 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: 12/08/2016
• Initial Report FDA Received Date: 01/03/2017
• 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