Model Number SN6AT3 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available the manufacturer internal reference number is: (b)(4).
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Event Description
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A consumer reported that following a cataract extraction with intraocular lens (iol) implant procedure, a line going through the implanted iol.Additional information was received stating the patient was out of town and fell off her bike and hit her head.The patient states that she fractured her cheek, broke one arm, and sprained the other.The cheek fracture was on the opposite side of her iol.She saw a physician who saw there was a crack in her lens.She later followed up with her regular physician, who stated that the line was probably there the whole time.She does not know if it was ever noted in her records prior to the accident.She also does not know if she even saw the line in her vision prior to her accident.
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Manufacturer Narrative
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Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received and stated that, the patient is still dealing with multiple issues.The patient met with surgeon and they feel at this time there is nothing they can do to help correct issues until other things are ruled out.
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Manufacturer Narrative
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The product was not returned for analysis; the lens remains implanted.Product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in this lot.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the patient fell off of their bike.The patient indicated that they suffered a fractured cheekbone, a broken arm and a concussion.Patient was unsure if they saw the line in their vision before the accident.The patient met with the surgeon and they feel at this time there is nothing they can do to help correct issues until other things are ruled out.Patient still having multiple issues related to the concussion.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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