Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Additional concomitant product - healon pro lot#: ue31597.Phone: (b)(6).The cartridge is not returning for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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It was reported that after a perfect preparation as per directions of use (dfu) of the zct100 lens, the doctor implanted the intraocular lens (iol) and discovered a little blue string.Through irrigation/aspiration (i/a) she was able to remove it.The surgeon kept the healon pro, the cartridge and the alcon tubing set with particle somewhere in it as well.No patient issues are being reported.Through follow-up we learned that the surgeon considers only the lens and the cartridge as suspect.It was confirmed that material is not returning.No additional information was provided.
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