CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report
Intraocular Lens (IOL) recalled by Aaren Scientific, Incorporated
Aaren Scientific is recalling Intraocular Lens (IOL), distributed in Alabama, Florida, Kansas. The recall was initiated on 13 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1309-2015
- FDA event ID
- 70557
- Recalling firm
- Aaren Scientific, Ontario, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Feb 2015
- FDA classified
- 20 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 13 Feb 2015 | Recall initiated by company | |
| 20 Mar 2015 | Classified by FDA | +35 days |
| 1 Apr 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Product as listed by the FDA
Intraocular 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.
Where it was distributed
Distributed in the states of OK, KS, FL, and AL.
Questions about this recall
Why was it recalled?
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Which lots are affected?
Serial No. 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 119071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1181331102, 1181321102, 1393231208, 1117161211, 1180941102, 1031031102, 1190261307, 1190231307, 1190091307, 1190101307, 1190431307, 1190441307, 1276591307, 1305951307, 1190071307, 1176951102, 1192921102, 1277111307, 1189541307, 1189551307, 1187761307, 1189531307, 1309911307, 1277101307, 1276941307, 1309961307.
Where was it sold?
Distributed in the states of OK, KS, FL, and AL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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