Corrected data: h6- health effect - impact code: "2199" should be removed and "4627" should be added.B5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -5.00 into the patients right eye (od).Reportedly "sterility broke, patient contact, they used back up lens".The lens was explanted and back up lens implanted device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found optic/haptic torn.Additional data: h6- type of investigation code: 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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