Data Foundry

Medical device recalls 2015

Intraocular Lens — Class II medical device recall Z-1309-2015

Terminated recall by Aaren Scientific, Incorporated, reported 2015-04-01, distributed in AL, FL, KS, OK. Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully complian

Recall numberZ-1309-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAaren Scientific, Incorporated, Ontario, CA, United States
Recall initiated2015-02-13
Classified2015-03-20
Reported by FDA2015-04-01
Terminated2015-06-29
DistributedAL, FL, KS, OK
Quantity28 units
Serial numbers1031031102, 1117161211, 1176951102, 1180941102, 1181321102, 1181331102, 1187761307, 1189531307, 1189541307, 1189551307, 1190071307, 1190091307, 1190101307, 1190231307, 1190261307, 1190431307, 1190441307, 119071307, 1192921102, 1276591307, 1276941307, 1277101307, 1277111307, 1305951307, 1309911307 and 2 more
Model numbersEC-3PAL

Product

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.

Reason for recall

Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1309-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.