Z-0097-06

CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)

Name: Z-0097-06 CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)
Creator: Advanced Medical Optics, Inc.
Published: 2005-10-05
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2005-10-05 / Terminated / root cause: packaging

FDA source

Advanced Medical Optics, Inc. began a recall of CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65) on 2005-10-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0097-06
Status: Terminated
Initiated: 2005-10-05
Posted: 2005-10-28
Terminated: 2008-05-23
Recalling firm: Advanced Medical Optics, Inc.
Product: CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece Anterior Chamber IOLs (Model: HSM65)
Product code: HQL Intraocular Lens
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 45 (4 in US)
Distribution: Nationwide, Austria, Belgium, Switzerland, Germany, Denmark, France, UK, Guadelope, Hong Kong, Croatia, India, Italy, Netherlands, and Vietnam
Product codes and lots: CeeOn¿ One-Piece PMMA HSM65, 2 lenses PMMA HSM HSM65+22,0 8054720508 8054730508

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)