510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Orion Vision

Marietta, GA, US

Orion Vision appears in FDA device records in Marietta, GA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Orion Vision carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Marietta Vision510(k), recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Orion Vision in 2005.

Clearances by year, as a table
510(k) clearance decisions for Orion Vision, by decision year
YearClearances
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K052606MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENSLPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Orion Vision, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10665781000140384Orion Vision1800 Sandy Plains Ind Prkwy, Marietta, GA 30066 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-1557-2011AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lensesProduct is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.Terminated

Verification record

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