MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC SOVEREIGN COMPACT CONSOLE; PHACOFRAGMENTATION UNIT

Model Number	CMP680300
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	02/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Manufacturer year 2015.The phacoemulsification machine was examined and tested at the customer location by an johnson & johnson (j&j) field service specialist (fss).The fss found no issues with the operation of the equipment.The fss was not able to duplicate the issue/error message reported.In addition, the handpiece used during the event was checked and tested.The fss found the handpiece working properly.The fss provided surgery support the following day and oriented the surgeon on the importance of priming before performing cataract procedure.The fss performed a field service checklist.The system was verified for all modes of operations.The system met j&j specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported a capsular tear resulting in an anterior vitrectomy surgical procedure.The surgery center indicated at the time of the event and during the procedure, the phacofragmentation unit stop working and error 212- phaco-vitrectomy-diathermy communication error master fault displayed.The surgery center indicated due to the equipment halting to a stop, it caused damage to the posterior capsule.The surgery center was able to complete the cataract procedure.The patient outcome is expected well.
Additional Manufacturer Narrative
A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is no significant change over historical complaint limits and no 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.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SOVEREIGN COMPACT CONSOLE
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7376502
• Report Number: 3006695864-2018-00605
• Device Sequence Number: 1543295
• 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,Followup
• Report Date (Section B): 04/26/2018

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: 02/28/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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 HANDPIECE SERIAL NO. (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR