Model Number AU00T0 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Eye Injury (1845); No Code Available (3191)
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Event Date 07/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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A sample product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Attempts to gather additional information were unsuccessful.(b)(4).
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Event Description
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A physician reported that during an intraocular lens (iol) implant procedure after the lens was in the capsular bag, a tear was noted in the anterior capsular bag rim near 12 o'clock, which was near the initial incision for the surgery.The lens was left implanted without indication of harm.The surgeon thinks that possibly the plunger could have caused the tear.
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Manufacturer Narrative
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This supplement is being filed to correct the value to adverse event and product problem.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A sample product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Attempts to gather additional information were unsuccessful.(b)(4).
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Event Description
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A physician reported that during an intraocular lens (iol) implant procedure after the lens was in the capsular bag, a tear was noted in the anterior capsular bag rim near 12 o'clock, which was near the initial incision for the surgery.The lens was left implanted without indication of harm.The surgeon thinks that possibly the plunger could have caused the tear.
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Search Alerts/Recalls
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