Model Number SOFTECHD+20.5 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
Unspecified Eye / Vision Problem (4471)
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Event Date 07/26/2022 |
Event Type
Injury
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Event Description
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Lenstec received an email stating, iol exchange due to haze/cloudiness.
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Manufacturer Narrative
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Based on the assessment of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, there have not been any other complaints from this batch.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification of our hema lenses.Microscopic examination of the lens revealed that the haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor is reviewing the case and a supplemental report will be provided once complete.
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Manufacturer Narrative
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Based on the assessment of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, there have not been any other complaints from this batch.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification of our hema lenses.Microscopic examination of the lens revealed that the haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor reviewed the case and states the patient's extensive comorbidities are likely the source of the haze/cloudiness seen.
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Event Description
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Lenstec received an email stating, iol exchange due to haze/cloudiness.
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Search Alerts/Recalls
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