ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Macular Edema (1822)
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Event Date 01/01/2010 |
Event Type
Injury
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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.Lorenzo iuliano, md, eleonora corbelli, md, andrea ramoni, md, francesco bandello, md, marco codenotti, md, unexplained visual loss after gas tamponade for macula-on retinal detachment.Incidence and clinical characterization.The manufacturer internal reference number is: (b)(4).
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Event Description
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A literature article unexplained visual loss after gas tamponade for macula on retinal detachment was received identifying the incidence rate and the clinical characteristics of unexplained visual loss after gas tamponade for primary macula-on rhegmatogenous retinal detachment.All subjects underwent a vitrectomy with gas procedure for the repair of retinal detachment.The outcome was unexplained visual loss after gas absorption in nine eyes.All patients had a central scotoma and microcytic macular edema.Endoillumination was set at thirty five percent.Perfluorocarbon liquid (pfcl) was used with retinopexy using cryopexy therapy.Standard medication included topical steroid and antibiotic association four times a day for 3 weeks and 1% tropicamide.This is the second of three reports for the third patient.
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Manufacturer Narrative
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Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.Based on the information available, the customer reported event cannot be confirmed.The root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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