Model Number MICL13.2 |
Device Problems
Defective Device (2588); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/24/2014 |
Event Type
malfunction
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Event Description
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A 13.2mm micl13.2 implantable collamer lens was reported as being defective (chipped) by the facility.There was no patient contact and the backup lens was used.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Pt age: unk.Pt weight: unk.Implant date: na.Explant date: na.Initial reporter: unk.(b)(4).Method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Conclusions: (no conclusion can be drawn): based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).
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Manufacturer Narrative
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Evaluation: method - device history record review.Results - a review of the device history record was performed and nothing was found in the manufacturing, packaging or shipping processes of this lens that was the root cause of the complaint.Conclusions - based on the complaint history, work order search, device history record review and the evaluation of the returned product, it is the most likely root cause that the lens damage and tear was caused by handling and manipulation of the lens by the user.(b)(4).
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Search Alerts/Recalls
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