The device and lens were returned in a biohazard bag in the opened carton.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully advanced.A broken haptic tip was observed smashed on top of the plunger in the nozzle at the wound guard.The round distal tip edge was located on the wrong side of the plunger.No damage was observed to the device.The plunger tip was flexed backward upon return.The lens was separate from the device.The optic was torn (cut) into two pieces and adhered atop each other in dried viscoelastic.One haptic was broken in the gusset area.The distal tip area of the broken haptic was broken, returned inside the device.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported event.The broken haptic was smashed on top of the plunger and the tip edge was located on the wrong side of the plunger.The trailing haptic position may indicate it was not in a proper position for advancement per the provided diagrams in the instructions for use (ifu).The plunger position in relation to the broken haptic during advancement cannot be determined.The ifu 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).
|