Based on the information reviewed, the event was attributed to use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.Zonular damage is an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).
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A patient underwent cataract surgery on (b)(6) 2019 where the miloop was intended to be used to section the cataractous lens into fragments.The company representative in attendance noted the surgeon experienced some difficulty inserting the miloop through the incision.Once the miloop was deployed, the surgeon was unable to rotate the wire loop.Upon microscopic examination, it was revealed that the device was not inserted to the proper depth (too anterior/shallow).The surgeon was unable to advance the miloop, so it was retracted and removed from the eye.The surgeon elected not to proceed with the miloop and the cataract was fragmented using phacoemulsification.After several minutes, the surgeon reported there was zonular damage and a capsular tension ring was inserted.The relationship between the zonular damage and the miloop is unknown.Additional information is being requested.
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