A health care professional reported that, a patient who underwent cataract surgery using an ophthalmic handpiece developed postoperative tass (toxic anterior segment syndrome) and fibrin was noted in the anterior chamber of the eye.The patient was treated with steroids, antibiotics, and nsaids (non-steroidal anti-inflammatory drugs) and topical medications three times a day.Symptom resolved the following day.The handpiece was tested and found to be occluded.Analysis of handpiece for during initial testing of the product by a third-party hospital for possible cultures resulted in identification of pseudomonas acnes.This is the one of eight-product report for this patient from the reporting facility related to the same event.
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Additional information is provided in sections d.9, h.3, h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, the phacoemulsification handpiece (hp) was returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) 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.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The handpiece was received for testing on this investigation.Noting, it could only be tested for functionality and not for any bioburdens as they were autoclaved once delivered.A visual assessment of the returned sample revealed no obvious non-conformity.The handpiece was connected to a calibrated resistance breakout test box, where the connection between the input and output impedance of the sensor was found to be within specifications.The resistance and dissipation between low electrode and high electrode were also tested for and found to both be within specifications.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the hp was measured and was found to be within specifications.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The irrigation and aspiration lines of the handpiece were flushed for particulates testing.The collected debris was isolated and microscopically analyzed and found to contain numerous dark fibers up to 1mm in length and a high number of metallic particles up to 70m in length on the filter.The analysis of the dark fibers found the best match to be cotton (natural fibers).The analysis of the metallic particles identified elements including carbon (c), oxygen (o), aluminum (al), titanium (ti), and vanadium (v).The presence of these elements along with the visual characteristics suggests the particles are likely from a titanium alloy.However, the exact origin of the fibers and metallic particles remains inconclusive.Based on the information obtained, the root cause is inconclusive and there is no indication that the handpiece manufacturing process contributed to the reported patient impact.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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