The Recall Desk

Manufacturer

Optimedica Corporation

2 recalls in our database name Optimedica Corporation as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-06-03

Of the 2 recalls from Optimedica Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1683-2015·2015-06-03

    OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters

    OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2014·2014-01-15

    Optimedica Catalys Precision Laser System Recalled for Transformer Heating Risk

    Optimedica is recalling 78 Catalys Precision Laser Systems worldwide due to a risk of transformer heating and smoke.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide