Evaluation summary: the product was not returned for analysis.Complaint history and product history records could not be reviewed because the report did not provide a lot number or any identification traceable to the manufacturing documentation.The file has been opened from a literature report.There is no indication in the report that the iol caused/contributed to the reported events.The literature report: new surgical approach in cases of cataract with ocular stevens-johnson syndrome, describe the intraoperative difficulties encountered in cases of ocular stevens-johnson syndrome as a result of a poor ocular surface, the presence of symblepharon, and varying degrees of corneal opacity with secondary poor visibility of anterior segment structures.The formation of cataract in cases of ocular stevens-johnson syndrome occurs at an early age as a result of ongoing intraocular inflammation and prolonged use of topical steroids to control the inflammation.The key to successful cataract surgery in these patients is optimization of the ocular surface preoperatively, a modified technique of phacoemulsification, and close postoperative follow-up.Additional information has been requested.(b)(4).
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In a literature article, the authors describe the intraoperative difficulties encountered in cases of ocular stevens-johnson syndrome as a result of a poor ocular surface, the presence of symblepharon, and varying degrees of corneal opacity with secondary poor visibility of anterior segment structures.Modications to the standard phacoemulsification technique enabled safe and successful completion of the surgery in theses cases.Table one describes s.No.1 is a (b)(6), male, right eye, pre-existing dense with adherent leucoma cataract, stevens-johnson syndrome, implanted with an sn60wf iol, postoperative complication filamentary keratopathy, treated with copious lubrication.The eye developed filamentary keratitis at 1 month, which subsided with preservative free lubricants, cyclosporine and low dose surface acting steroids.Additional information has been requested.There are four medical device reports associated with this literature article.This report is for the first patient.
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