Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable as this device is not an implantable device.If explanted, give date: not applicable as this device is not an explantable device.Concomitant products: intraocular lens, model aab00, serial unknown and phaco handpiece, sn (b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.Device evaluation: the product evaluation could not be performed as no sample was returned for investigation.The reported complaint cannot be confirmed.Manufacturing records review: a manufacturing record review was performed and no deviation related to this complaint is reported in the manufacturing record.A search of complaint system revealed no similar complaints have previously been reported on this batch.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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