Visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.The lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.Medical review - according to use fmea (failure modes and effect analysis) it has been determined that excessive vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition; poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular ciliary sulcus or ciliary sulcus cyst).Several conditions may arise from this event (i.E.Pupillary block, malignant glaucoma, increased iop etc.).To prevent any of these complications from occurring, staar recommends that the lens be explanted and/or exchanged with the right size once the surgeon determines that this condition may affect the outcome of the patient's vision.Pupil block with elevated iop in the presence of a vicmo/vticmo model may occur due to: remaining viscoelastic in the posterior chamber, oversized icl with angle closure, too narrow angles/crowded ac due to small eye anatomy preoperatively, unexpected abnormal anatomy or tissue abnormalities (presence of iris/ciliary body cysts), blockage of the port by remaining viscoelastic, or by an inflammatory membrane, etc.Based on the complaint history, work order search, medical review and the evaluation of the returned product, a probable root cause of excessive vaulting has been determined to be related to the inaccuracy of the white to white measurement or a mismatch between white to white and the sulcus to sulcus diameter.(b)(4).
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