CATALYS PRECISION LASER SYSTEM - MAIN UNIT (2015-03-10) — recall 53495
Health Canada — Medical Devices · Canada · 2015-04-14 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: AMO quality assurance was notified of a complaint that a patient's left eye was treated with a right eye template. The left eye cataract incisions template was selected as a starting basis for patient treatment planning. From there the right eye/ left eye cataract incisions template buttons were toggled which caused right eye cataract incisions template numbers to be auto populated into the left eye template. This is a software anomaly which translates into a potential incorrect treatment at an occurrence rate higher than established in the risk management file.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.