Catalog Number 8065750469 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Macular Edema (1822); Inflammation (1932); Loss of Vision (2139); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)
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Event Date 05/10/2022 |
Event Type
Injury
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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 physician reported that after cataract surgery on the left eye, the patient felt pain, vision reduced (vision loss) and there was a reaction in the anterior chamber cell (++) and tyndall (+).There was a mild conjunctival inflammation and diagnosed with toxic anterior segment syndrome.The patient was examined and result shows aqueous cell 2+ and increase in macular edema and the patient received an intravitreal injection with triesence.The patient was prescribed with post operative steroids, antibiotics and non-steroidal anti-inflammatory drugs.Additional information received clarifying the reporter suspects phacoemulsification handpiece for the events.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional corrected information received indicating that the suspect product is ophthalmic handpiece and not the ophthalmic visco surgical device.
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Manufacturer Narrative
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Specific product identifiers (serial numbers) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown.Therefore, a service history review cannot be performed.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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