It was reported that after the intraocular lens (iol) was fully inserted in the right eye, the patient had a collapsed capsule, which was not a lens issue, but a patient anatomy issue.The iol was removed and replaced with a non-johnson & johnson iol.One suture and a vitrectomy was required.There was no injury reported.The patient is doing fine post-operatively.The device was discarded.No further information was provided.
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Patient weight: unknown; requested but not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.The device was not returned for evaluation as it was discarded.Therefore; a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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