The manufacturer reviewed the on-site service documentation which confirmed that the device was working within specification.The investigation has not identified any abnormality or product deficiency related to the incident.The manufacturer reviewed the document labelling for visumax laser keratome.The user manual (ifu 000000-1345-518-doks-sm-kr-211114, p.6-9) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure.Moreover the user manual describes headache, dry eye, visual disturbance as side effects that can be associated with the visumax laser procedure.The user manual also advises the healthcare professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.
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On 11/29/2018, carl zeiss meditec (czm) received a voluntary report (mw5081613) from the fda submitted by a patient who underwent a relex smile surgery on (b)(6) 2018 with the visumax device and collagen-cross linking (cxl).Cxl is a treatment that is provided by a third party company and it is not in the responsibility of czm.Per the report, the patient's eye sight was not corrected to 1.0 after the surgery - the patient's vision on the left eye was reported to be 0.5 while the right eye was reported to be 0.6.The patient reported seeking other doctors' opinions.They communicated to the patient that this is an irregular astigmatism which cannot be corrected by glasses.The patient reported experiencing numerous side effects such as headaches, nausea, double vision, blurry vision, ghosting, glare, starburst, shadows, dry eye, eye burning, eye pain, floaters and ectasia.Treatment videos and patient information were requested from the eye clinic in (b)(6), but due to local regulations, it has not been provided.The patient's pre-operative conditions are currently unknown and stable post-operative information were not provided for each eye.
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