Z-2802-2011

iSert Intraocular Lens (Model PC-60AD)

Name: Z-2802-2011 iSert Intraocular Lens (Model PC-60AD)
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 iSert Intraocular Lens (Model PC-60AD) 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-2802-2011
Status: Terminated
Initiated: 2011-06-17
Posted: 2011-07-14
Terminated: 2012-11-29
Recalling firm: Hoya Surgical Optics, Inc.
Product: iSert Intraocular Lens (Model PC-60AD)
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: 33,743 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 7355 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)