Additional information: breakdown of the 5 events of is as follows: cartridge damaged,lens damaged 4.Lens damage 1.Serial or lot numbers of suspect products (b)(4).Unknown 1.4 investigations were completed and 1 are pending from the period.From the 4 investigations: product was returned and no issues were found.In all the investigations 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 file.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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