The device and the lens were returned loose in the carton.The plunger lock and lens stop were removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.There is no damage observed to the device.The iol was returned outside the device, adhered to the posterior of the tip in dried solution.The lens was removed and then cleaned using lphse to further assess.One haptic tip is scuffed.The optic is scratched and the optic edge is scraped.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined.The lens was returned outside of the device with damage observed.It is unknown if the observed lens damage was due to the reported complaint of too much resistance when inserting".The damage to the haptic may indicate the lens was not in the proper position for advancement.The dfu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).
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