Section a2, a4, a5: unknown/asked but unavailable (asku).Section b3: date of event: unknown/not provided.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 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.¿ attempts have been made to obtain missing information.However, the account did not provide the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that a preloaded monofocal intraocular lens (iol) had a small scratch, but smooth insertion.It was reported they think it might be associated with the cartridge of the inserter possibly scratching the periphery of the lens.Through follow up it was learned that the lens was removed and replaced without complication.There was no patient injury, nor, no other medical/surgical intervention outside of the standard of care was required.No other information was provided.
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