Model Number SY60WF |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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A physician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, postoperative pigment was adhered behind intraocular lens (between the intraocular lens and the posterior capsule) immediately after surgery in a case after implanting the lens.Insufficient removal of the ophthalmic viscosurgical devices (ovd) at the time of irrigation and aspiration was suspected in the case.The sample was not available as it still remains in the patient's eye.Additional information was received stating patient's symptom was improving.It was reported that there was possibility of patient injury.There are two medical device reports associated with this complaint.This report is 1 of 2.
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Manufacturer Narrative
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The product was not returned for analysis; the lens remains implanted.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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Manufacturer Narrative
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The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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