FDA Medical Device Recalls (openFDA)
Hoya Surgical Optics, Inc.: iSert Intraocular Lens (Model PC-60AD)
- Recall number
- Z-2802-2011
- Recalling firm
- Hoya Surgical Optics, Inc.
- Product
- iSert Intraocular Lens (Model PC-60AD)
- Status
- Terminated
- Initiated
- 2011-06-17
- Posted
- 2011-07-14
- Terminated
- 2012-11-29
- Reason
- 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.
- 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 customercare@hoyasurgopt.com.
- Quantity
- 33,743 units total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQL
- Firm FEI
- 3006723646
- Firm city
- Chino Hills
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28