Catalog Number CBV92000079 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Corneal Ulcer (1796); Red Eye(s) (2038); Eye Infections (4466)
|
Event Date 11/26/2021 |
Event Type
Injury
|
Event Description
|
An optician reported that a consumer experienced "infection, double ulceration of the cornea and red eyes" after wearing contact lenses.The current status of the consumer's eye is not known at the time of this report.Additional information and product sample have been requested but not yet received this is the second of two product reports associated with the same patient.It is unknown which product lot is associated with each respective eye.
|
|
Manufacturer Narrative
|
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.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.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.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|