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

Model Number	CMP680300
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Vitreous Loss (2142); Vitrectomy (2643)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Manufacturer year 2014.The phacoemulsification machine was examined and tested at the customer location by an amo field service specialist (fss).The field service found no issues with the operation of phacoemulsification unit.The fss inspected the vitrectomy cutter function and found the vitrectomy to be working properly.The fss demonstrated the vitrectomy cutter to the surgeon and staff by increasing the cut rate.The fss performed a field service checklist.The system was verified for all modes of operations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgeon reported vitreous loss resulting in an unplanned vitrectomy.A brief description from the surgery center indicated during the cataract extraction procedure, there was vitreous loss resulting in an unplanned vitrectomy procedure.In addition, the surgery center indicated the vitrectomy cutter was not working and the vitrectomy cutter was replaced to complete the procedure.
Additional Manufacturer Narrative
A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document 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.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: 6168323
• Report Number: 3006695864-2016-00983
• Device Sequence Number: 10856889
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 03/16/2017
• 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: VITRECTOMY CUTTER
• Outcome Attributed to Adverse Event: Required Intervention