Model Number SN60WF |
Device Problem
Malposition of Device (2616)
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Patient Problem
Blurred Vision (2137)
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Event Type
Injury
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Event Description
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A health care professional reported that, following the intraocular lens (iol) implant procedure, the patient experienced decreased vision and it just continued to get worse.When patient looks up she could see the outline of the iol.The patient states no trauma or incident occurred.The physician diagnosed dislocated lens bag complex.The lens bag complex was bobbing about in the anterior vitreous.The physician repositioned the iol and performed vitrectomy.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint of decreased vision and dislocated.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information in the file indicated that the patient was referred for evaluation of a dislocated iol.The patient stated decreased vision and continued to get worse.When patient looks up she can see the outline of the iol.Dr.Diagnosis was dislocated lens bag complex left eye.The lens bag complex was bobbing about in the anterior vitreous.The file indicated that the lens was repositioned.No further information has been provided.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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