The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -10.0 diopter, in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to excessive vaulting, elevated intraocular pressure (pupillary block), narrowing of the angle, angle closure, shallowing of the anterior chamber and iris prolapse.The patient experienced blurred vision.A secondary surgery was performed to laser the peripheral iridotomies and the lens was repositioned but the patient still had pressure issues.The lens was exchanged for a shorter lens.The patient's pupil has remained large with some shallowing of the anterior chamber but the issue has improved.The patient's post-op best-corrected visual acuity was 20/20.
|
Method: (process evaluation): device history record review.Result: (no failure detected): based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, product evaluation, medical review and device history record review, a specific root cause of the event could not be determined.(b)(4).
|