Catalys Precision Laser System-Catalys — Class II medical device recall Z-1683-2015
Terminated recall by Optimedica Corporation, reported 2015-06-03, distributed nationwide. Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided
| Recall number | Z-1683-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optimedica Corporation, Sunnyvale, CA, United States |
| Recall initiated | 2015-02-20 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CO, DE, EG, ES, FR, GB, HK, IN, IT, JP, KR, NL, SG |
| Quantity | 171 distributed |
| Reason classes | software |
| Serial numbers | 44055211, 44055411, 44055711, 44056012, 44056112, 44056212, 44056312, 44056412, 44056512, 44056612, 44056712, 44056912, 44057112, 44057212, 44057312, 44057412, 44057512, 44057712, 44057812, 44057912, 44058012, 44058212, 44058312, 44058512, 44058612 and 111 more |
| Model numbers | ALYS-1 |
Product
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Reason for recall
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
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-1683-2015. 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.