Model Number 1MTEC30 |
Device Problem
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 01/10/2018 |
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 abbott medical optics has been submitted.
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Event Description
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It was reported that an intraocular lens (iol) came out of the cartridge with some kind of material.The account commented that the material was like a thin film or like the piece of capsule you take out when you do a capsulorhexis.The customer used three (3) cartridges with the same problem.There was patient contact with two of the three cartridges, but no patient injury.Three mdrs will be filed.This report is the third of three.
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Manufacturer Narrative
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Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints 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 and the reported issue could not be verified.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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