OptiMedica Catalys Precision Laser System — Class II medical device recall Z-0066-2019
Terminated recall by Johnson & Johnson Surgical Vision Inc, reported 2018-10-10, distributed in CO, GA, IL, MD, PR. Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on th
| Recall number | Z-0066-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Johnson & Johnson Surgical Vision Inc, Milpitas, CA, United States |
| Recall initiated | 2018-05-09 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2021-01-13 |
| Distributed | CO, GA, IL, MD, PR |
| Countries outside the US | AT, DE |
| Quantity | 9 |
| Reason classes | software |
| Serial numbers | 44065613, 44106215, 44107315, 44109015, 46120916, 46123116, 46124617, 46131418, 46131618 |
Product
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Reason for recall
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
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-0066-2019. 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.