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No Description Available

Tag No.: A0288

Based on interviews and documentation review, it was determined the Hospital had not (yet) developed and implemented a Corrective Action Plan related to a finding identified in its Investigation of the SRE involving Patient #1.

Findings included:

A review of the Hospital Internal Investigation related to the SRE involving Patient #1 (incorrect loading of the IOL Delivery System Cartridge resulting in the lens being delivered in the wrong position and a zonular dehiscence when the Ophthalmologist rotated the lens) revealed the Investigation identified issues related to timely Incident Reporting.

A Corrective Action Plan related to this finding had not been fully developed and implemented.