Reported Apr 1, 2015 · Terminated
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,…
Aaren Scientific, Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aaren Scientific, Incorporated · 4290 E Brickell St Ste A · Ontario, CA · 91761-1569
Is this the product you have?
- Intraocular Lens (IOL), Part No. EC-3 PAL
- Diopter17.5, 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
- Lot codes and dates
Serial No. 1181331102118132110213932312081117161211118094110210310311021190261307119023130711900913071190101307119043130711904413071276591307130595130711907130711769511021192921102127711130711895413071189551307118776130711895313071309911307127710130711813311021181321102139323120811171612111180941102103103110211902613071190231307119009130711901013071190431307119044130712765913071305951307119007130711769511021192921102127711130711895413071189551307118776130711895313071309911307127710130712769413071309961307
- Amount recalled
- 28 units
Where it was sold
Why it was recalled
Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
This product could cause temporary or reversible health problems — stop using it.
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