MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SOVEREIGN COMPACT CONSOLE; PHACOFRAGMENTATION UNIT

Model Number	CMP680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	08/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The phacoemulsification machine was examined and tested at the customer location by an amo field service specialist (fss).In addition, a phaco specialist visited the site location.Both amo representatives provided surgery support.The surgeon acknowledged using aggressive settings in phaco and aspiration mode.The amo reps verified the surgeon was using high settings and were out of normal standards of cataract procedures.The parameters were adjusted.After the adjustment of the parameters, the surgeon reported cataract surgeries were satisfactory and the surgeon was much more comfortable with the equipment the fss performed a field service checklist.The system was verified for all modes of operations and calibrations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The surgery center reported two patients experiencing corneal edemas after cataract procedure using a phacoemulsification unit and there was a possibility of corneal transplants required.Through follow up, the surgeon had indicated the patients are having improvements and getting better monitored by surgeon and no surgical intervention required.Although several attempts were made for additional information, no further information was provided.This report is for patient 1 of 2.

• Brand Name: SOVEREIGN COMPACT CONSOLE
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5919726
• Report Number: 3006695864-2016-00814
• Device Sequence Number: 945688
• Product Code: HQC
• UDI-Device Identifier: 05050474514706
• UDI-Public: (01)05050474514706
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2016

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: CMP680300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/31/2016
• 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