iSert Intraocular Lens (Model PC-60AD)

FDA device recall Z-2802-2011 · posted 2011-07-14 · Terminated

Recall details

Recalling firm

Hoya Surgical Optics, Inc.

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.

Action taken

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 customercare@hoyasurgopt.com.

Root cause

PMA

Status

Terminated

Product code

HQL

Quantity affected

33,743 units total

Distribution

Nationwide Distribution

Date initiated

2011-06-17

Date posted

2011-07-14

Date terminated

2012-11-29

Location

Chino Hills, CA