Additional information: breakdown of the 3 events is as follows: cartridge crack, cartridge tip cracked/damaged: 2, cartridge tip cracked/damaged: 1.Lot numbers of suspect products: ce02260 - 2, ce02263 ¿ 1.2 investigations were completed and 1 is pending from the period.From the 2 completed investigations, the products were not returned.In the investigation it was concluded that products met manufacturing release criteria and no product deficiency was identified.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
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