The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -7.0 diopter, in her left eye (os).The patient reported she had lost vision during her pregnancy and the vision has not returned.The patient is now wearing contacts.The lens remains implanted.
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Per medical review: patient completed 36 month follow-up form following icl implantation stating that she had experienced decrease in visual acuity during pregnancy so she had to wear contact lens again.No report of any secondary surgically or medically intervention performed and no report of loss of bcva.According to data clarification request, received on (b)(6) 2015, icl was implanted bilaterally in 2012 and the patient was last seen on (b)(6) 2013 with no noted issues (va ou: 20/20).No additional information was received to date from any other doctor.It should be noted that hormones produced during pregnancy and/or breastfeeding can change eyesight so per dfu: "the visian icl is contraindicated in patients who are pregnant or nursing".A work order search found no similar complaint.Based on the complaint history, work order search, and medical review, a specific root cause of the event could not be determined.(b)(4).
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