A physician reported that after intraocular lens implant surgery the patients experienced with toxic anterior segment syndrome.Additional information has been requested.Additional information received indicating a surgeon reported that an ophthalmic phacoemulsification handpiece had white specimens, discoloration in the lumens, and potential pitting during a cataract surgery.The patient experienced toxic anterior segment syndrome (tass) post-operatively.The patient presented post-operative day 19 vitreous cell and floaters with no pain or erythema and no anterior chamber reaction.Upon examination of the patient, the surgeon noted aqueous cell and conjunctival inflammation.The patient was prescribed with post-operative steroid eye drops and antibiotics.No cultures were performed.The patient's symptoms have been improving without any additional treatment.
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The phaco handpiece was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation/aspiration lines and nose cone as well as discoloration inside the aspiration line.The phaco handpiece was then flushed for particulates testing.The sample was visually and microscopically analyzed and found to contain numerous clear fibers and blue fibers up to 900m and 1.6mm in length respectively.Microscopic examination also shows numerous black particles and reflective particles up to 150m and 80m in length respectively.The fibers and particles were isolated and analyzed.The analysis found the blue fiber and clear fiber to best match cotton.Analysis of the black particles identified carbon (c), oxygen (o), sodium (na), magnesium (mg), aluminum (al), silicon (si), sulfur (s), potassium (k), calcium (ca), titanium (ti), chromium (cr), and iron (fe).However, the exact identity of the black particles is unknown.Analysis of the reflective particles identified carbon (c), aluminum (al), titanium (ti), and vanadium (v).The presence of these elements along with the visual characteristics suggests the reflective particles are a titanium alloy.However, the exact origin and quantity of the fibers and particles remains inconclusive.A flow rate test was performed on the irrigation and aspiration lines of the phaco handpiece which found the phaco handpiece to meet product specifications.The returned phaco handpiece was connected to a calibrated vision system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet alcon specifications.Although the existence of foreign material was able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.It should be known that handpieces are inspected during manufacturing for metal particulates.The inspection approach taken follows a statistically valid continuous sampling plan.No nonconformities were observed during manufacturing of this handpiece.The root cause of the reported event is inconclusive.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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