Date of event: date unknown.First name: unknown.(b)(6).The system was evaluated by a field service engineer.The field service found inverter was not working properly.The inverter was replaced.A field service checklist was performed.The unit complied with all factory settings.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.
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In initial report, the manufacturer year provided was inadvertently reported as 4/26/2008, however the correct date is 4/23/2008.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
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