The reporter indicated that a 12.6mm vticmo12.6 implantable collamer lens of a -16.0/2.0/095 was implanted by the surgeon into the patient's right eye (od).Concomitant product information used intraoperatively including viscoelastic and delivery system type were not provided.Per the reporter, "one year after the initial surgery and day 1 after surgery to increase spherical power", toxic anterior segment syndrome (tass) was diagnosed.Pupil fibrin was observed.Diagnostic cultures were not performed but antibiotic and steroid ophthalmic drops as well as oral steroids were prescribed.Visual acuity was noted as of (b)(6) 20224 to be improved from 1.0 (~20/20) to 1.2 (~20/15).The lens remains implanted.
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A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Manufacturer's narrative: a review of the device labeling was completed.The directions for use states a contraindication for implantation in eyes (7) suspicion of iritis, or past history.Iritis is identified in the labeling as a known potential adverse event following icl implantation.The reporter states the initial lens implanted one year earlier was replaced for a different lens power and tass was diagnosed day 1 upon implantation of the replacement lens.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.To date the icl remains implanted.Claim# (b)(4).
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