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Model Number DIU150 |
Device Problem
Unstable (1667)
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Patient Problems
Nausea (1970); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/09/2023 |
Event Type
Injury
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Event Description
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Patient reported that toric intraocular lens was implanted on (b)(6) 2023 in her right eye and the next day she was unable to see.Patient explained that there is a huge half- moon shadow from the 12 o'clock until the 6:00 o'clock and that she saw five layers stacked.These visual problems had affected her for the last year.Patient is disappointed, upset and reported that she has been terminated from a job as a result of making mistakes due to her visual issues.Few months ago, eye drops were prescribed to shrink eye pupil but his failed and made her unstable, dizzy, nauseous.Glasses were also tried but did not work.She reported that her surgeon insists the lens is properly implanted but that she had gone to four (4) other eye specialists and been told by 3 of them that the lens is out of alignment.The lens was explanted and replaced with a non jnj distance vision only lens in a secondary procedure.
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Manufacturer Narrative
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H6 - health effect - clinical code 4581 used for device decentered or dislocated or tilted subluxated or wrong position.Product investigation: the product was not returned for evaluation.A record review was performed and no product deficiency identified as all units were released within specification.Based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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