Lot Number 222 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Conjunctivitis (1784); Inflammation (1932); Uveitis (2122)
|
Event Date 08/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The product is not available for evaluation as it was discarded.A review of the lot batch records concluded that the product was formulated and manufactured according to local and global specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is ongoing.
|
|
Event Description
|
A distributor reported a consumer was diagnosed with conjunctivitis while using the product.Follow-up with the consumer provided additional information.The consumer reported they were diagnosed with keratoconjuntivitis after visiting a doctor.The consumer was prescribed floxal drops every hour and an unknown ointment for nighttime.Medical records indicate that at the follow-up visit on the next day, the consumer''s right lids were calm and weak injection on the conjunctiva was present.Consumer was diagnosed with keratitis and uveitis.At the follow-up visit with eye care practitioner, consumer was instructed to continue using floxal drops, the unknown ointment for nighttime use, and tobrex drops were added.
|
|
Manufacturer Narrative
|
The product is not available for evaluation as it was discarded.A review of the lot batch records and testing of retain samples concluded that this product was formulated, manufactured, and packaged according to local and global product specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
|
|
Search Alerts/Recalls
|