Catalog Number CBVUNK00148 |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Scratched Material (3020)
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Patient Problems
Corneal Abrasion (1789); Eye Infections (4466)
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Event Type
Injury
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Manufacturer Narrative
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The complaint sample has not returned for evaluation.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.This is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to qs#(b)(4) for the second report.The manufacturer internal reference number is: (b)(4).
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Event Description
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As initially reported by consumer on behalf of her daughter that after wearing the lenses consumer experienced scratch on black part of eye, corneal abrasion and had infection.The consumer was treated with unspecified eye drops as physician suggested.The current status of consumers eye is unknown at the time of the reporting.Additional information has been requested but not yet received.
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Manufacturer Narrative
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H3:, h6: the lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information received has been updated in b5 and h6.H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received, according to which scratching of the eye was caused by the pressure from the suction on lenses that made it difficult to remove from the eye.Consumers also mentioned that the lenses were rough.The current state of consumer eyes is unknown at the time of this reporting.
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Manufacturer Narrative
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The additional information regarding the power of the lens has been reported.H.3., h.6.: the actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.D.4.: this is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported lot number 31479758 the manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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