MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC SOVEREIGN COMPACT; UNIT, PHACOFRAGMENTATION

Model Number	CMPR680300
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, ethnicity - there was no patient involvement.Event date is unknown, not provided.Email is unknown, not provided.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The customer reported that their sovereign compact system was smoking.The system has been unplugged and moved to a safe area.No injury was reported.
Additional Manufacturer Narrative
Correction: h6: type of investigation code should have been 4114 and not 3331, 4109 and 4110.The device evaluation was not performed at the time of submission of initial report.

• Brand Name: SOVEREIGN COMPACT
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12103682
• Report Number: 3006695864-2021-08027
• Device Sequence Number: 14450385
• Product Code: HQC
• UDI-Device Identifier: 05050474514782
• UDI-Public: (01)05050474514782
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMPR680300
• Device Catalogue Number: CMPR680300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1