Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Phone: (b)(4).Device evaluation: the device was not returned, the complaint issue reported could not be verified and product deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that during a cataract surgery, the preloaded device did not lock and the surgeon saw the intraocular lens going into the patient's eye unexpectedly.Afterwards the lens was removed during the same procedure, with no issue for the patient.No other information was provided.This report address the device with serial number (b)(4).The other suspect products will be captured in two other mdrs.
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