Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Blurred Vision (2137); Vitrectomy (2643); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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No serial number reported (b)(4).Secondary surgical intervention, explant and cataract surgery with iol implantation.(b)(4).
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Event Description
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Article stated that the patient's past ocular history was significant for placement of visian icl several years earlier for the treatment of high myopia.Most recently, the left eye (os) icl was removed secondary to dislocation.Cataract surgery was performed and a ct lucia iol was implanted.It was reported that the patient tolerated the procedure well.The postoperative course was uncomplicated, and the patient retained excellent distance ucva.
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Manufacturer Narrative
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Corrected data: an article stated that the patient's past ocular history was significant for placement of visian icl several years earlier for the treatment of high myopia.Most recently the left eye (os) icl was removed secondary to dislocation.For unknown period of time after the icl removal the patient's left eye experienced loss of vision.Extreme zonular instability was reported.Cataract surgery and vitrectomy was performed with a replacement ct lucia iol; and sutures were used to close the wound.It was reported that the patient tolerated the procedure well.The postoperative course was uncomplicated and the patient retained excellent distance ucva.(b)(4).Claim# (b)(4).
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Manufacturer Narrative
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Corrected data: "extreme zonular instability after lens removal" not included in the initial mdr.Claim# (b)(4).
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Search Alerts/Recalls
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