Lot Number ASKU |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Scarring (2061); Ulcer (2274)
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Event Date 11/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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The lot number has not been provided, however two unique identifiers were reported for this patient (contact lens powers -3.50 and -5.00 ); at the time of this report, it is not known which contact lens power is associated with the event.This report is being submitted to represent the contact lens power of -3.50 reported; an additional report will be submitted under manufacturer's reference number 2017-29638 to represent the -5.00 high power reported.The complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined." (b)(4).
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Event Description
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It was reported, on (b)(6) 2017, by an optician that, consumer wore this type of contact lenses since 2012 and was diagnosed with an ulcer on (b)(6) 2016.Additional information received on 04/14/2017 indicating that left eye (os) central was affected.It was reported that the consumer visited the eye care provider (ecp) three times (dates unspecified) and was prescribed an unspecified antibiotic with unspecified treatment regime.The consumer was refit into a daily wear lens, a light scar is visible.No additional information is known at this time.
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Manufacturer Narrative
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The previously reported contact lens power of -3.50 high contact lens was not confirmed to be part of the complaint and is not considered a suspect product in the reportable event previously submitted on 04/28/2017.Please reference the manufacturer internal reference number is: 9610813-2017-00009 for information regarding the reportable event that occurred.
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Event Description
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Additional information received on 04/28/2017 indicating that left eye (os) with -5.00 power was affected.No additional information is known at this time.
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Search Alerts/Recalls
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