Section a2, a4, a5 patient information: asked.Information unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is on or before feb 29, 2024.Section d6a, if implanted, give date: asked.Unknown/not provided.Section d6b, if explanted, give date: asked.Unknown/not provided.Section h3-other (81): the device has not been received 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.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 3, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint product was visually inspected under magnification revealing that the lens was stuck in the cartridge and overridden by the plunger rod.Ovd was observed inside the cartridge.The lens module was opened and inspected and no issues were observed.The lens could not be removed from the cartridge without damaging the lens and/ or cartridge.No issues that could cause or contribute to the complaint issues were observed.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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