Correction: on initial mdr the fda product problem of 2338 was an error.It should have been 4010 on the original mdr ¿ (corrected information provided in h.10.) additional information reported in h.3., h.6.And h.10.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the ifu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the ifu, only qualified company viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the ifu and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).
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