Z-2801-2011

iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an...

Name: Z-2801-2011 iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an...
Creator: Hoya Surgical Optics, Inc.
Published: 2011-06-17
License: https://open.fda.gov/license/

Hoya Surgical Optics, Inc. / initiated 2011-06-17 / Terminated

FDA source

Hoya Surgical Optics, Inc. began a recall of iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens... on 2011-06-17. The reason FDA records is "The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2801-2011
Status: Terminated
Initiated: 2011-06-17
Posted: 2011-07-14
Terminated: 2012-11-29
Recalling firm: Hoya Surgical Optics, Inc.
Product: iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to the iris where the lens will replace the optical function of the natural crystalline lens. However, accommodation will not be replaced. The optic of this lens is designed to produce negative spherical aberration. The Hoya iSymm Model FC-60AD Intraocular Lens is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
Product code: HQL Intraocular Lens
Reason for recall: The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.
FDA root cause: PMA
Action: Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at [email protected].
Quantity in commerce: 61,617 units total
Distribution: Nationwide Distribution
Product codes and lots: This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 4522 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.

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)