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Terminated

iSert Intraocular Lens (Model PC-60AD)

FDA Recall Z-2802-2011 · Posted 2011-07-14

Recalling FirmHoya Surgical Optics, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2011-06-17
Date Terminated2012-11-29
Product Quantity33,743 units total

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.

Firm 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].

Root Cause

PMA

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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