Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: rupture. Device evaluation: visual analysis of the returned device identified: underweight, black particles in the gel/ surface of the shell and broken shell. A microscopic analysis was performed which identify a sharp edge opening assessed as unidentified tear opening. A dimension measurement in the shell was performed which identify the thickness within specification. Based on the device analysis the final assessment is: a sharp opening posterior side assessed as an unidentified (tear) opening.
Patient Sequence No: 1, Text Type: N, H10
Healthcare professional reported a left side rupture. The device has been explanted and replaced.
Patient Sequence No: 1, Text Type: D, B5