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Model Number TV60ML |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 06/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.If implanted, give date: not applicable, as the healon 5 pro is not an implantable device.If explanted, give date: not applicable, as the healon 5 pro is not an implantable device.The intraocular lens (iol) is not returning for evaluation as it was discarded by customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that a patient experienced capsular entrapment syndrome, experiencing some level of 2-3 diopter shifts following cataract surgery, requiring an immediate post-operative yttrium aluminum garnet (yag) laser for correction.Issue was a result of residual healon 5 pro ovd remaining in the eye, potentially posterior to the iol, following surgery, even after what the surgeon describes as meticulous irrigation/ aspiration (ia) removal.The patient is doing fine, and progressing nicely according to the surgeon, and he has made the clinical decision to return to usage of the healon duet pro ovd product as a solution.Product was discarded and is not being returned.No additional information was provided.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and (b)(4).
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Search Alerts/Recalls
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