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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth is unknown as it was not provided.Patient gender is unknown as it was not provided.Date of event is unknown as it was not provided.First and last name is unknown as it was not provided.Telephone (b)(6).Manufacturer year 2016.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The surgery center reported corneal edema on some patients after cataract procedure using a phacoemulsification unit.A brief description from the surgery center indicated the surgeon had mentioned 5 to 6 patients were affected.Follow up revealed the phacofragmentation system was working fine but the surgery center was using old tips.The surgery center purchased new tips.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: field service specialist (fss) checked system and found no issue.
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.The review of the device history record (dhr) for compact console showed that there were no issues or non-conformities.Manufacturing has been ruled out as a potential cause for the reported issue.No conclusive evidence identified for reported issue.The system was working within amo specifications.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: SOVEREIGN COMPACT CONSOLE
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6783803
• Report Number: 3006695864-2017-00609
• Device Sequence Number: 13825586
• Product Code: HQC
• UDI-Device Identifier: 05050474514706
• UDI-Public: (01)05050474514706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2017

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: CMP680300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/03/2017; 10/27/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/28/2017; 11/24/2017
• 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: PHACO TIPS
• Outcome Attributed to Adverse Event: Other