ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR
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Model Number III |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility representative reported an intraocular lens (iol) delivery system, "the haptic is getting stuck in the injector." additional information was requested.
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Manufacturer Narrative
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Additional information provided in d.11., g.1., and g.2.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A company iii injector sample was not received at the manufacturing site for evaluation for the report of the haptic is getting stuck in the injector; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot record reviews could not be conducted.Because an injector sample was not received at the manufacturing site and no lot information was provided, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in d.11., g1., and g.2.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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