It was reported that when surgeon was implanting the simplicity iol, while attempting to pull back the plunger, it would not release from the iol.This required the use of a second instrument (mushroom) to manipulate the iol to free from the plunger.Unfortunately, this resulted in an anterior capsule tear.However, the tear was not sufficient to have any impact on the patient outcome.Iol was implanted as intended and patient outcome has been fine.No additional intervention performed.
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If explanted, give date: not applicable as the lens remains implanted.Initial reporter telephone number: (b)(6).The device is not returning for evaluation as to date it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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