A surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, after opening the box with the iol, was found that the optical part was damaged.Another iol was ordered.The surgery day was postponed to another day.The iol was unpacked according to the instructions.Additional information was provided that there was no contact between the iol and the patient.The defect was detected while opening the container.The patient's natural lens was removed before the defect was found.The operation was postponed to the next day.A similar lens was implanted that next day.The patient's condition is good.
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Product evaluation: the product was not returned.A photo was provided of the lens incorrectly in the lens case.There appears to be marks/scuffs on the optic of the lens.Due to the poor quality of the photo, the nature of the damage and the presence of viscoelastic cannot be determined.Product history records were reviewed and the documentation, indicated the product met release criteria.Based on our observation of the attached photo, the lens appears to be damaged.The presence of clinical solution on the lens cannot be confirmed.It is difficult to make a determination, of handling/ damage without evaluation of the physical sample.A final root cause cannot be determined, based on available information.The manufacturer internal reference number is: (b)(4).
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