The reporter indicated that the surgeon implanted a 12.1mm vicm5 12.1.-13.0 diopter, into the patient's right eye (od) on 23/sep/2023.The lens was explanted due to edophthalmitis, blurred vision, and toxic anterior segment syndrom(tass) on 28/sep/2023.Patient was given intravitreal antibiotics and vitreous tap was sterile.Cause of event reported as unknown.Reportedly, inflammation reduced significantly post explant.
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H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).
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