This initial and final emdr is being submitted to fda for outside us like products reporting.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Injector was available for investigation.The iol was ejected out and wasn't returned.No abnormalities were found in production and inspection records of the product.(serial no: (b)(6); model: nc1-sp).Trace of lubricant (hpmc) was found inside the injector.The exact root cause of the event was not determined.From our investigation, we believe this event was not caused by our product quality.A review of the complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.
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Event occurred in germany.It was noted that hpmc was used intra-operative complications, posterior capsule rupture, imdrf code: a051102: share edges reportedly, injector caused capsule rupture on anterior capsule leaf when pulled out.Upon deployment of the iol there was a capsular rupture in the posterior capsule leaflet.Upon pulling out the injector there was a capsular rupture near the rexis at the anterior capsular leaflet.The lens was not explanted.Patient health impact: minor injury.
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