Model Number SN6AT7 |
Device Problem
Overcorrection (3006)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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A sample product was not returned for analysis.The complaint and product history cannot be reviewed as there was no device identifying information provided by the reporter.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.The manufacturer internal reference number is: (b)(4).
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Event Description
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An account manager reported that a patient was overcorrected by 1.25 diopters of cylinder in the right eye post cataract surgery with toric intraocular lens implant (iol).Additional information received states the iol was rotated.
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Manufacturer Narrative
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Based on information provided by the facility, the root cause was determined to be unrelated to the product.The healthcare professional indicated that the complaint lens product did not cause or contribute to the event.The file details indicate the surgeon rotated the lens as suggested by (b)(6).The vision improved.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was provided by the physician, that in his opinion, the iol did not cause or contribute to the event.No cause was reported.The patient¿s prognosis is excellent.
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Search Alerts/Recalls
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