OptiMedica Catalys Precision Laser System — Class II medical device recall Z-1515-2015
Terminated recall by Abbott Medical Optics, Inc., reported 2015-04-29, distributed nationwide. Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentati
| Recall number | Z-1515-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical Optics, Inc., Milpitas, CA, United States |
| Recall initiated | 2015-02-20 |
| Classified | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2019-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CA, CH, CL, CO, DE, EC, EG, ES, FR, GB, GR, GT, HK, IN, IT, JP, KR, MX, NL, PE, SA, SG, TH, TR |
| Quantity | 202 |
| Serial numbers | 44055211, 44055311, 44055411, 44055611, 44055711, 44055811, 44055911, 44056012, 44056112, 44056212, 44056312, 44056412, 44056512, 44056612, 44056712, 44056812, 44056912, 44057112, 44057212, 44057312, 44057412, 44057512, 44057612, 44057712, 44057812 and 177 more |
Product
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Reason for recall
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
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-1515-2015. 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.