CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)
FDA Recall Z-0097-06 · Posted 2005-10-28
Recalling FirmAdvanced Medical Optics, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2005-10-05
Date Terminated2008-05-23
Product Quantity45 (4 in US)
Reason for Recall
A small opening (channel or tunnel) in the seal of the
outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
Firm Action
A product notification letter was mailed to all US domestic customers via overnight carrier (Federal Express) beginning on October 5, 2005. A global notification letter will be translated into the local languages by the international AMO affiliates and mailed to international customers as soon as a listing of all customers is tabulated.
Root Cause
Other
Distribution Pattern
Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.