Advanced Medical Optics, Inc. CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)
Brand
Advanced Medical Optics, Inc.
Lot Codes / Batch Numbers
CeeOn¿ One-Piece PMMA HSM65, 2 lenses PMMA HSM HSM65+22, 0 8054720508 8054730508
Products Sold
CeeOn¿ One-Piece PMMA HSM65, 2 lenses PMMA HSM HSM65+22,0 8054720508 8054730508
Advanced Medical Optics, Inc. is recalling CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65) due to 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 package. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026