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The lens was not returned for evaluation.A photo was provided in the file.The image is of a computer monitor.Shown on the right side of the screen is the used ultrasert device from mid nozzle through tip held above the eye.The plunger was oriented correctly.There appears to be viscoelastic in the device.The plunger was retracted toward mid-nozzle.The lens was shown outside the device on the left side of the screen held pinched in the end of fine metal tweezers.Viscoelastic was observed on the lens.The lens was in a folded position, as would be expected of a lens being delivered through a device.The leading haptic was partially visible and was in an extended position.The trailing haptic appears to be misfolded and appeared to be broken in the gusset area.The distal trailing haptic area appears to be looped backward at the midpoint of the optic.The trailing haptic gives the appearance that a plunger underride has previously occurred.It is difficult to make confirmations from the grainy photo clarity.No further determinations can be made without a physical product.Only the used company device was returned loose in a bag with a surgical sponge for evaluation.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid-nozzle.No damage was observed.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause could not be determined for the reported complaint.The lens was not returned for evaluation.Based on our observation of the attached photo, the haptic appeared to be damaged and clinical solution appears to be present on the lens.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.Broken haptics may occur due to the use of a non-qualified viscoelastic.The use of an unqualified (ovd) opthalmic viscosurgical device may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (23 degree celsius per 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event.The file will be reopened if the sample or additional information becomes available.The manufacturer internal reference number is: (b)(4).
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