Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The… — Class II medical device recall Z-2154-2015
Terminated recall by Bausch & Lomb Surgical, Inc., reported 2015-07-29, distributed nationwide. Haptics breaking during lens loading and insertion.
| Recall number | Z-2154-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Surgical, Inc., Clearwater, FL, United States |
| Recall initiated | 2015-05-26 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, DE, ES, FR, GB, GR, IN, KR, MY, NO, RU, TW, UA |
| Lot numbers | 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707, 4456710, 4456711, 4456712, 4456713, 4456714, 4456715, 4456716, 4456717, 4456718, 4456719, 4456720, 4456721, 4456722, 4456723, 4456724, 4456725, 4456726, 4456727 and 460 more |
Product
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Reason for recall
Haptics breaking during lens loading and insertion.
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-2154-2015. 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.