The complainant indicates the use of a non company viscoelastic, which is not qualified for use with associated iol model/ cartridge.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow ifu, as the surgeon states the use of a non-qualified combination.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).
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