ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR
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Model Number ACU0T0 |
Device Problems
Mechanical Problem (1384); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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.A qualified viscoelastic was indicated.The root cause cannot be determined for the reported event of plunger override.The product was not returned to evaluate.Information was provided that stated the product would not be returning because the lens was successfully implanted.The reporter indicated that the surgeon was attempting to implant the lens & when the plunger over rode the lens, the lens was then removed from the plunger & loaded the lens on a cartridge using an injector they were able to implant the lens.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A health professional reported a lens loading issue during intraocular lens implant.Additional information received; a preloaded lens was used and the plunger went over the lens.The lens was successfully implanted without patient harm.Additional information received, the surgeon was attempting to implant the lens when the plunger over road the lens.The lens was then removed from the plunger and loaded into a cartridge using an injector they were able to implant the lens.
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Search Alerts/Recalls
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