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

Ontario, CA, US

AAREN SCIENTIFIC INC appears in FDA device records in Ontario, CA. FDA records list one 510(k) clearance, 44 PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
44
Recall records
6
Registered establishments
2

FDA records under these names

2 names

FDA records resolved to Aaren Scientific Inc. 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.

  • Aaren Scientific, Incorporatedenforcement report, recall
  • Carl Zeiss Meditec Production, LLC.registration, PMA

510(k) clearance history

FDA records hold 1 510(k) clearance for Aaren Scientific Inc. in 2013.

Clearances by year, as a table
510(k) clearance decisions for Aaren Scientific Inc., by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K123888Z CARTRIDGE IOL DELIVERY SYSTEMMSSSubstantially Equivalent

Registered establishments

FDA registered establishments for Aaren Scientific Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30132025653013202565AAREN SCIENTIFIC INC9010 Hellman Ave, Rancho Cucamonga, CA 91730 US2026
30101262683010126268Carl Zeiss Meditec Production, LLC.1040 S VINTAGE AVE BLDG A, Ontario, CA 91761 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-0071-2018AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.The recommended storage temperature on the label is incorrect.Class IITerminated
Z-1309-2015Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device 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. Aaren Scientifics EC-3 IOLs are intended 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 by phacoemulsification.Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.Class IITerminated
Z-1079-2012UV-Absorbing Posterior Chamber IOL Model: SP-65A2, Serial Number: 1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, 1168581106, 1168591106, 1168601106, 1168611106. The device 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 Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.Terminated
Z-1078-2012UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 1167231106, 1167241106, 1167251106, 1167261106, 1167271106, 1167281106, 1167291106, 1167301106, 1167311106, 1167321106, 1167331106, 1167341106, 1167351106, 1167361106, 1167371106, 1167381106, 1167391106, 1167401106, 1167411106, 1167421106, 1167431106, 1167441106, 1167451106, 1167461106, 1167471106, 1167481106, 1167491106, 1167501106, 1167511106, 1167521106, 1167531106, 1167541106, 1167551106, 1167561106, 1167571106, 1167581106, 1167591106, 1167601106, 1167611106, 1167621106, 1167631106, 1167641106, 1167651106, 1167661106, 1167671106, 1167681106, 1167691106, 1167701106, 1167711106, 1167721106, 1167731106, 1167741106, 1167751106, 1167761106, 1167771106, 1167781106, 1167791106, 1167801106, 1167811106, 1167821106, 1167831106, 1167841006, 1167851106, 1167861106, 1167871106, 1167881106, 1167891106, 1167901106, 1167911106, 1167921106, 1167931106, 1167941106, 1167951106, 1167961106, 1167971106, 1167981106, 1167991106, 1168001106, 1168011106, 1168021106, 1168031106, 1168041106, 1168051106, 1168061106, 1168071106, 1168081106, 1168091106, 1168101106, 1168111106, 1168121106, 1168131106, 1168141106, 1168151106, 1168161106, 1168171106, 1168181106, 1168191106, 1168201106, 1168211106, 1168221106, 1168231106, 1168241106, 1168251106, 1168261106, 1168271106, 1168281106, 1168291106, 1168301106, 1168311106, 1168321106, 1168331106, 1168341106, 1168351106, 1168361106, 1168371106, 1168381106, 1168391106, 1168401106, 1168411106, 1168421106, 1168431106, 1168441106, 1168451106, 1168461106. The device 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 Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.Terminated
Z-1077-2012Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device 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 Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.Terminated
Z-1076-2012Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 The device 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 Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.Terminated

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