ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Injury (2348)
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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.(b)(4).
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Event Description
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A customer reported that six patient's experienced anterior capsule tears during surgery.The customer requested the phacoemulsification handpiece be evaluated.Additional information was received from the customer indicating the tears in the in the anterior capsule were with the same set of instruments over the last several weeks.Since it was noticed in the exact same part of the anterior capsule during irrigation and aspiration of cortex, it was thought that the problem might be with the i/a handpiece.However, the i/a handpiece was switched out and the problem persisted.
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Manufacturer Narrative
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To date no accessories or equipment has been returned for evaluation.The importance of an intact capsulorhexis for safe phacoemulsification is well recognized.In fact, irregular edges are known to promote radial tearing.Prior to the innovation of the continuous curvilinear capsulorhexis, it was widely known that extensions of tears most often occur in v-shaped notches (or peaks as noted in the report description) of the anterior capsule rim.The determinant of the direction of tearing is the sum of the vector forces of the surgeon¿s hand during the capsulorhexis and the tension applied by the zonular fibers.Published data suggests that patients with dense cataracts may be at greater risk of capsular rupture due to the additional forces created within the bag during surgery.It is noted that the strength of the capsule in laser assisted procedures are as good as or greater than a manual capsulorhexis and the smoothness of the capsulotomy edge is similar to manually created openings.The elasticity of the capsule is known to increase the incidence of anterior capsule tears as well as size of continuous curvilinear capsulorhexis.An opening that is too small is more conducive to striking the edge of the capsulorhexis with the phaco tip or secondary instruments.There is no evidence indicating that the integrity of the anterior capsule was compromised by the performance of the phaco handpiece.The phaco handpiece was manufactured on february 8, 2018.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event was not able to be confirmed.The root cause cannot be determined conclusively.(b)(4).
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Manufacturer Narrative
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The phaco handpiece was received and a visual assessment of the returned sample found no visual nonconformity.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 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 product specifications.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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