ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
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Model Number IV |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/14/2023 |
Event Type
malfunction
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Event Description
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A healthcare professional reported that, after intraocular lens implantation surgery, a small fissure was evident next to the proximal haptic, right where the injector plunger makes contact with the lens.Additional information was received stating the symptoms were improving.There are 2 reports associated with this file, this is 2 of 2.
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Manufacturer Narrative
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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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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of small fissure next to the proximal haptic; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; 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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One opened company handpiece was received for the report of small fissure next to the proximal haptic.The returned sample was visually inspected and found to be non-conforming, with white and clear foreign material observed on the mouth and face surface all the way down the plunger, inside and corner of the barrel.A dimensional test was performed for plunger height position and deemed conforming.A functional test was performed for thread engagement and plunger movement through the barrel and deemed conforming.The foreign material was sent for analysis.Particle analysis was performed using microscopic fourier transform infrared spectroscopy (micro ft-ir) and identified the best match to be wypall fibers (natural fibers) and ophthalmic viscosurgical devices (ovds).A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be nonconforming visually with foreign material in the mouth of the plunger and along the plunger.Particle analysis found the foreign material to best match ovd and wypall fibers.Ovd and wypall fibers are not used in the manufacturing of packaging process of the company injector.How and when the ovd and wypall fibers got on the injector can not be determined, but the most likely root cause is from use during surgery as the injector has been in service for approximately 21 months.If the foreign material was present on the injector prior to use, it could be a contributing factor to damage on the lens.The instructions for use provide detailed cleaning instructions and instruct to inspect the inject prior to use.The manufacturer internal reference number is: (b)(4).
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