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Model Number 7167X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyperemia (1904); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Additional information: date of event: unknown/no information, best estimate is during (b)(6) 2021.Expiration date: unknown as the lot # was not provided.Unique identifier (udi) number: udi is unknown since the lot number was not provided.Telephone number: (b)(6).Device manufacture date: unknown as the lot# was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
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Event Description
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Consumer reported that her eyes turned red and irritated after wearing her contact lenses which she maintained with concept 1-step solution.This was the consumer¿s first time using this solution.Her eyes were red every day after using the solution.She visited an eye clinic and eye drops were prescribed however she did not recover.She visited another eye clinic and was informed to use epika, a product she previously used.After using epika her red eyes subsided and fully recovered.Consumer was using concept 1-step to remove stains from her contact lenses.She figured this was wrong because the stains were not removed.Consequently, she used concept rinsing solution, but her red eyes persisted.Consumer did not provide any more information.This report is being submitted for the solution.A separate report is being submitted for the neutralizing tablets.
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Manufacturer Narrative
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Corrected data: section d4: in the initial mdr a comment to address section d4 for the lot number was not provided in section h10, therefore, it is being provided in this follow-up report.Section d4 lot number is unknown, not provided.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing record review: a review of the manufacturing records and complaint history could not be performed as the product lot number was not provided.Conclusion: based on the investigation results, no product deficiency was 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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