A4-a6: unk.Manufacture narrative: a review of the device labeling was completed.Inflammation not limited to: iritis(iridocyclitis), fibrin precipitation, and cells in the anterior chamber are identified in the labeling as a known potential adverse event following icl implantation.The dfu provides the surgeon instruction for lens implantation and complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe and require extended steroid treatment.Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event.Mechanical insult to the iris can result in a prolonged or stronger inflammatory response.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim #(b)(4).
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The reporter indicated that the surgeon implanted an implantable collamer lens (icl) into the patient's left eye (os) on (b)(6) 2024.The patient underwent bilateral (ou) implantation of icls same day.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.Reportedly, the patient presented day 1 and day 7 with excellent vision ou without inflammation.At the month 1 visit, pigment was noted on the icl with few cells and "suggestion of fibrin on central port".Visual acuity was reported to be 20/20 (1.0) in both eyes (ou).The patient was prescribed increased topical steroids for the left eye (os).To the best of our knowledge the lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
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