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Model Number 1MTEC30 |
Device Problems
Break (1069); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that during implantation of an intraocular lens (iol), or while pulling the injector out of the patient's eye, a small piece of plastic broke off the cartridge.Reportedly, the plastic piece was removed without injury.No further information was provided.
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Manufacturer Narrative
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Device available for evaluation? yes.Returned to manufacturer on: 06/06/2018.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed traces of viscoelastic at the cartridge tip.The cartridge was observed deformed/cracked (split).The visual inspection does not reveal a molding defect.The conditions of the returned sample suggested that the cartridge tip could have been broken with the handpiece push rod.The customer's reported complaint for cartridge broken was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators inspect the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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