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Model Number Z9002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Visual Disturbances (2140); Dizziness (2194)
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Event Date 10/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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If explanted, give date: not applicable, as the lens remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site as the lens remains implanted; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no additional complaint was received from this production order.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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The patient reported that he has been feeling dizzy after implant of an intraocular lens (iol) in the right eye.The patient also reported seeing floaters and after wearing eye glasses he complains of headaches.The patient indicated that he cannot read for more than 20-30 minutes at a time because of the headaches, therefore, he has a difficult time focusing.His vision at night is not as clear, so he is not comfortable driving at night.The patient had a prk (photorefractive keratectomy) performed on (b)(6) 2019, and is still in the healing process.At this time, the lens remains implanted.No additional information was provided to johnson & johnson surgical vision.Patient had bilateral lens implants.This report represent the lens implanted in patient's right eye.
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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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Search Alerts/Recalls
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