Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Rapid progression of the epiretinal membrane after intravitreal aflibercept injection ji min kwon, md, myung shin lee, md, kang yeun pak, md, hyun woong kim, md, phd j korean ophthalmol soc 2018:59(10):98-988 issn 0378-6471 (print) issn 2092-9374 (online).The manufacturer internal reference number is: (b)(4).
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A literature report indicated a patient experienced a retinal pigment epithelial tear, in the left eye, 10 days following pars plana vitrectomy to repair epiretinal membrane.Subretinal fluid and cysts were observed at the side part of concave by oct.An intravitreal injection was performed.After the injection, only cicatrix was left in the part of concave and it has been stabilized.
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