Catalys Precision Laser System — Class II medical device recall Z-0649-2014
Terminated recall by Optimedica Corporation, reported 2014-01-15, distributed nationwide. Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the su
| Recall number | Z-0649-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optimedica Corporation, Sunnyvale, CA, United States |
| Recall initiated | 2013-12-20 |
| Classified | 2014-01-08 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, DE, DO, ES, FR, GB, JP, NL, SG |
| Serial numbers | 44000811, 44055211, 44055311, 44055411, 44055611, 44055711, 44055811, 44055911, 44056012, 44056112, 44056212, 44056312, 44056412, 44056512, 44056612, 44056712, 44056812, 44056912, 44057012, 44057112, 44057212, 44057312, 44057412, 44057512, 44057612 and 53 more |
Product
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Reason for recall
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
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-0649-2014. 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.