Section a2, a4 and a5: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that after the preloaded intraocular lens (iol) had been implanted into the eye, the surgeon noticed a mark on the optic.The surgeon removed and replaced the iol during the same procedure.The patient is reported as fine.Through follow up, we learned that this occurred in the left eye (os) and that no further medical or surgical interventions were required.No further information is available at this time.
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Corrected information: in the report submitted feb 28, 2024 ((b)(4)), an incorrect catalog number was inadvertently submitted.This report contains the corrected catalog number.Section d4 - catalog #: dib00i0200.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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