510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hoya Surgical Optics, Inc.

Irvine, CA, US

HOYA SURGICAL OPTICS, INC. appears in FDA device records in Irvine, CA. FDA records list one 510(k) clearance, 46 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
46
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Hoya Surgical Optics, Inc. in 2009.

Clearances by year, as a table
510(k) clearance decisions for Hoya Surgical Optics, Inc., by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081346HOYA IS INJECTOR SYSTEMMSSSubstantially Equivalent

Registered establishments

FDA registered establishments for Hoya Surgical Optics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30067236463006723646HOYA SURGICAL OPTICS, INC.110 Progress Ave., Suite 175, Irvine, CA 92618 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2802-2011iSert Intraocular Lens (Model PC-60AD)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.Terminated
Z-2801-2011iSymm 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.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.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain