The reporter indicated that the surgeon implanted a 12.6mm micl12.6, -9.5 diopter, implantable collamer lens, into the patient's right eye (os) on (b)(6) 2016.Lens opacity (asc) was observed on 15/jan/2019.Glare/haloes and blurred vision was also observed.Lens remains implanted.Reportedly, "halos since surgery, at night.Alphagan helped.
|
Additional information: h6 type of investigation- analysis of production records 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Corrected data: b3-date of event in initial mdr should be reported as (b)(6) 2018.Claim# (b)(4).
|