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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80849

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Johnson & Johnson Surgical Vision Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0066-2019
Recall number
Z-0066-2019
Initiated
May 09, 2018
Classification
Class II
Status
Terminated
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

Model: Catalys Precision Laser System, CE 0044: Catalys-U (US version) Serial Numbers: 44065613 - software cOS 5.00.33 install date 4/27/2018 46131618 - software cOS 5.00.33 install date 4/23/2018 46131418 - software cOS 5.00.33 install date 4/30/2018 44107315 - software cOS 5.00.33 install date 5/1/2018 46120916 - software cOS 5.00.33 install date 4/23/2018 46123116 - software cOS 5.00.33 install date 5/2/2018 44106215 - software cOS 5.00.33 install date 5/3/2018 Catalys-I (International version) Serial Number: 44109015 - software cOS 5.00.33 install date 5/1/2018 46124617 - software cOS 5.00.33 install date 5/3/2018

Distribution pattern

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