Catalog Number CBVUNK00017 |
Device Problem
Material Deformation (2976)
|
Patient Problems
Eye Injury (1845); Ulcer (2274); Discomfort (2330)
|
Event Date 10/21/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The complaint sample has not returned for evaluation; the lot number is unknown.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).
|
|
Event Description
|
As initially reported by a female consumer via telephone on (b)(6) 2020 states in the past consumer found a folded lens after opening the blister.The consumer experienced discomfort and irritation when wearing the lens.Upon visiting a doctor the consumer was diagnosed with ulcer.Anti-inflammatory and anti-bacterial eye drops were prescribed and contact lens wear was discontinued for unknown period.Upon follow-up visit, symptoms recovered.Additional info has been requested but not yet available.
|
|
Manufacturer Narrative
|
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).
|
|
Search Alerts/Recalls
|