Model Number 09081X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Red Eye(s) (2038)
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Event Type
Injury
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Manufacturer Narrative
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Age/date of birth: unknown, information not provided.Date of event: exact date unknown, information not provided.Incident date provided only as (b)(6) 2020.Expiration date: unknown as the lot number for the tablets was not provided.Unique identifier (udi#): unknown as the lot number for the tablets was not provided.Manufacture date: unknown as the lot number for the tablets was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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A consumer reported that his eyes were hurting upon insertion of contact lenses after using oxysept 1-step solution.After removal of the contacts, his eyes were red.The consumer was examined by a physician and was diagnosed with irritated eyes due to using oxysept 1-step solution.The consumer was prescribed an eyedrop medication, name of the medication was not provided.The consumer has used this brand of product for a few years and followed the directions for use.The product was first opened in (b)(6) 2020 and incident date is noted as (b)(6) 2020.Additionally, the consumer has not had lasik surgery, does not have allergies and is not a smoker.The consumer has recovered.No further information has been provided.This report captures the event for the neutralizing tablets.A separate report is being submitted for the solution.
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Manufacturer Narrative
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This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
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Manufacturer Narrative
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Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: june 14, 2020.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A few tablets were received at hangzhou with the complaint sample and those tablets were used in the dissolution test.Moreover, the results of the complaint sample were within the specified limit and of the finished product specification requirements.The sample was within specifications.Manufacturing records review: a review of the records could not be performed as the product lot number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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