EyeGility Inserter

Description of Event or Problem

The Healthcare Facility reported that during a right eye intraocular lens (IOL) implantation, a posterior capsule rupture occurred. The IOL unexpectedly and forcefully ejected from the injector during insertion. The capsule was perforated, the zonule was detached and the IOL was in the vitreous without remaining capsular support. The corneal incision was enlarged to remove the IOL and a suture was placed. The patient was left aphakic and dexamethasone/neomycin sulfate eye drops were prescribed. At three (3) day post-surgery the intraocular pressure (IOP) was 21 mmHg, with corneal edema, minimal temporal conjunctival hyperemia, and mild pain described as a foreign body sensation. A follow -up appointment was scheduled to plan a secondary implant procedure with a different IOL type.

Additional Manufacturer Narrative

The device is not available for evaluation as it was discarded. A review of the device history record (DHR) did not identify any anomalies or nonconformities that could be related to this event. The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates. Based on the available information, the root cause could not be conclusively determined.