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The customer reports ¿inflammation with negative cultures in two instances.' this investigation will serve as the first investigation of the two.The same hand piece was used for both patients.Questionnaires were sent out, but were not returned by the customer.However, the handpiece was returned for evaluation to the company by the customer.Additional related information was requested but was not obtained.Without information, the reported event cannot be determined conclusively.The customer reported possible toxic anterior segment syndrome (tass) or endophthalmitis while using the system.The most common causes of tass are identified as follows in order of prevalence: inadequate flushing of phaco, irrigation/aspiration handpieces and cannulated equipment, use of enzymatic cleaners and detergents, use of reusable cannulas, inadequate cleaning of instruments, use of preserved epinephrine, reuse of single use devices, use of tap water with no sterile water final rinse, inadequate personnel or trays to allow proper preparation of instruments, no immediate cleaning allowing ophthalmic viscoelastic device (ovd) and surgical solutions to dry on instruments, use of preserved medicines in the eye, reuse of tubing for flushing, latex bulbs for irrigation, not training, no terminal sterilization, instruments stored on towels, touching of iol or patient contact areas of instruments with gloved hands, off-label use of lidocaine gel, poor instrument maintenance, autoclave residue, rust, particulates, lint, use of powdered gloves, additives added to balanced salt solution against directions for use (dfu) , improper use of prep solutions, detergents and cleaners, failure to follow manufacturer¿s directions for use, including no air flush, use of unapproved enzymatic cleaners, use of postoperative ointment in clear corneal cases, povidone-iodine placed in the eye at the end of procedures, incorrect concentration of detergents and enzymatic cleaners.The phacoemulsification systems are closed systems.They are operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of tass.These findings continue to validate the need to follow the recommendations detailed in the dfus, aorn recommended practices, and the ascrs tass task force guidance document.There are multiple factors that could contribute to the occurrence of endophthalmitis.A patient¿s ocular flora or microorganisms that have colonized the surface structures (eyelids and conjunctiva) are the usual cause of infection, therefore isolating eyelids and eyelashes from the surgical field is crucial.The most common cultured microorganisms are gram-positive coagulase negative cocci (70%) with staphylococcus epidermis (s.Epidermis) the most prevalent.Deoxyribonucleic acid (dna) analyses of s.Epidermis strongly suggest that it is likely that commensal bacterial contaminating the anterior chamber at the time of surgery are responsible for most cases of endophthalmitis.Negative cultures were confirmed for the patient, by the surgeon.There were no cultures taken of the returned samples.Antibiotics used days before surgery has been shown to decrease the bacterial load at the time of surgery.Povidone-iodine solution has broad antibiotic activity and has been shown to significantly decrease conjunctival and perilimbal flora.Meticulous prepping and draping of the patient before surgery are important as well, to isolate the eyelids and lashes from the surgical field.Finally, attempts should be made to decrease any postoperative patient risk factors, such as immunosuppression or systemic disorders that may affect the wound healing and the ability of the eye to ward off any inoculums of bacteria during cataract surgery.Intraoperative risk factors may be associated with an increased incidence of postoperative endophthalmitis.These include inadequate disinfection of the eyelid or conjunctiva, vitreous loss, or unplanned/unapparent ocular penetration.The handpiece was received for evaluation.A visual assessment of the returned sample showed no visible nonconformities.The handpiece was flushed for metal particulates testing.The sample was visually and microscopically analyzed and found to contain dark natural fibers up to 620 ¿m in length, opaque plastic appearing particles up to 300 ¿m in length, and small reflective particles up to 35 ¿m in length.The dark natural fibers were identified and best match cotton.The opaque particles were identified and best match poly (methyl methacrylate).The reflective particles were observed to contain elements including carbon, oxygen, aluminum, phosphorous, sulfur, chlorine, titanium, and vanadium.The presence of these elements identifies the reflective particles as titanium.However, the exact origin and quantity of these particles remains inconclusive.The handpiece was then 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.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.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.The handpiece was manufactured on october 5, 2016.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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