Model Number SN60WF |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 02/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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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An inventory management specialist reported that during an intraocular lens (iol) implant procedure, a capsular tear occurred.Additional information was provided by the initial reporter that the procedure was completed the same day with a different lens.There was no patient harm.
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Manufacturer Narrative
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Mdr 1119421-2018-00320, is being canceled due to information received following submission of the initial report, that the intraocular lens (iol) never came in contact with the patient.This would indicate that the iol could not have contributed/caused the capsular tear.(b)(4).
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Event Description
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Additional information was provided that the lens did not come in contact with the patient.The lens was opened during cortex removal and this is when the small hole was noticed in the capsule.
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Search Alerts/Recalls
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