NIDEK Recall - FOI Response Register

1. I would be grateful if you could confirm the number of patients who were in receipt of the affected lenses per the recall notice attached.

Zero

2. I would be grateful if you could confirm the number of patients who suffered adverse consequences associated with the lenses and the date adverse consequences were reported/Datix completed.

N/A

The relevant time period is short – 1 October 2022 to 1 February 2023 and we do not anticipate a significant number of patients or reported issues, albeit the consequences may be particularly serious. The issue was reported by MHRA under reference (NatPSA/2023/003/MHRA) and a Device Safety Information notification was issued on 26 January 2023 under reference DSI/2023/001.