The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the visual outcome of the patient post-operatively was not as expected.The patient underwent an additional surgical procedure to have the rayone emv rao200e explanted and exchanged."deviation from target refraction" and "iol replacement or extraction" are listed in the "adverse events" section of the rayone ifu.There are many factors which may influence the post-operative outcome of the patient including but not limited to; incomplete removal of ovd following iol implantation (capsular block/capsular bag distension syndrome), dry eye during biometry measurement, incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), incorrect power selection (not using optimised a-constants may be a contributory factor in this scenario - surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.), posterior synechiae, irregular capsular bag contraction, patient medical history (e.G., glaucoma, pseudoexfoliation syndrome), lens decentration or dislocation, incorrect or unstable fixation within the capsular bag, post-operative rotation of the lens, lens does not fit anatomy of the eye (e.G., too large or too small), capsulorhexis diameter too large and induced surgical astigmatism.There is insufficient information to establish the cause of the deviation in target refraction in this case.Rayner is following up via its in-country representatives to obtain additional information.The return of the explanted iol is also being sought for evaluation.
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