Model Number MA60AC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intraocular Infection (1933)
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Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, patients came in post-operative follow-up and he found to have infection and reaction.Unspecified medical or surgical intervention was performed as a result of the event.Additional information was requested, but further no information was available.
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Manufacturer Narrative
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Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The investigation shows the manufacturing of the seven reported lens took place over the span of ten month at two different facilities.The fact that the lenses were manufactured in two different countries/manufacturing facilities would not preclude the issue being related to the manufacturing site.Follow up attempts were made.At this point, no further information available at this time.The file will be reopened if additional information is received.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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