If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.The device was not returned for analysis as it was discarded by the customer.The serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Parent information.
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It was reported that the customer noticed that the trailing haptic was missing from the intraocular lens (iol).The doctor mentioned that he is able to see the iol (under the microscope) while it¿s still in the inserter and can tell when it will happen.If he sees it, he requests a new iol.Instead of the trailing haptic folding up nicely, it folds into an inverted ¿u¿ almost and when the inserter is pulled out, the haptic comes with it.The doctor believes the problem lies with the pre-loaded iol inserter.The iol¿s when inserted in the eye are very inconsistent in the way they unfold, often the haptics are stuck together and have to separated bi-manually, or the trailing haptic is stuck behind the optic requiring further manipulation.The plunger pushing the iol forward is inconsistent on how it meets the trailing haptic, sometimes missing the iol completely leaving it in the inserter, sometimes not folding the trailing haptic at all leading to tearing the haptic off the iol as the inserter is removed from the eye.Also, the plunger will fold the trailing haptic in the middle of the haptic forming a u shape stressing the iol haptic junction.Further information was provided for this case: the lens was in contact with the patient¿s eye and the issue was not noticed prior to lens insertion, it was fully delivered into the eye.The lens was removed and replaced with a back-up lens during the same procedure.The affected eye was the left eye.There was no incision enlargement, vitrectomy or sutures required.There was no other medical or surgical intervention needed.The patient was fine when discharged.The lens is not available to return.No additional information was provided to johnson and johnson surgical vision, inc.
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