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Model Number 550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Capsular Bag Tear (2639)
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Event Type
Injury
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Event Description
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A health care professional reported, while performing cataract removal surgery, the capsule bag ruptured, necessitating a vitrectomy.However, an intraocular lens (iol) was not implanted in the patient's right eye during surgery.This complication is likely related to the patient's posterior subcapsular cataract.
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Manufacturer Narrative
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H.3., h.6.: 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.Alcon lensx (site #3008772169) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center site #2028159).The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A manufacturing device history record review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Service history was reviewed for the system.There was no service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record opened.The system found to meet all cosmetic and performance standards.The customer reported event cannot be confirmed.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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