Additional information: sections a-2 patient age/date of birth, a-4 patient weight, and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed during the initial procedure, therefore not explanted.Section h3-81: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h-6 health effect - clinical code: 4581 - poor capsule support (eye anatomy issue).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Correction: patient date of birth and gender information was provided with device return.The following fields were updated accordingly: sections a2: patient date of birth: (b)(6) 1961, sections a3: patient gender: male previously reported as no information.Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 18-dec-2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a sterilization pouch.The complaint lens was inspected under magnification.The lens was inside a sterilization pouch.The lens was coated in viscoelastic residue and was cleaned.The cleaned lens presented with scratches on the optic body.Complaint issue "positioning issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications and the reported complaint issue could not be confirmed.No product deficiency or product malfunction was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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