# FDA recall Z-0066-2019

> **Johnson & Johnson Surgical Vision Inc** · Class II · device recall initiated 2018-05-09.

## 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.

## Distribution

US Distribution to states of: CO, GA, IL, MD including Puerto Rico and internationally to countries of: Austria and Germany.

## Key facts

- **Recall number:** Z-0066-2019
- **Recalling firm:** Johnson & Johnson Surgical Vision Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-09
- **Report date:** 2018-10-10
- **Termination date:** 2021-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milpitas, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0066-2019

## Citation

> AI Analytics. FDA recall Z-0066-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0066-2019. Source: US FDA. Licensed CC0.

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