Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70672

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

Open FDA event record

Event summary

Timeline bucket
February 20, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Optimedica Corporation

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.

How coverage and grouping work

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

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.

Z-1683-2015
Recall number
Z-1683-2015
Initiated
February 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
Optimedica Corporation
Quantity
171 distributed Worldwide

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.

Code information

Software version 3.00.05: Serial numbers - US: 44066413 44063113 44065413 44066213 44102714 44060012 44064813 44061012 44061812 44101614 44068314 44056612 44063713 44102614 44068914 44073514 44074814 44061612 44073714 44056312 44061412 44066613 44069414 44069814 44070914 44072714 44073014 44073114 44074514 44074614 44100714 44068014 44060612 44062813 44066914 44056012 44062213 44064513 44101014 44100814 44060312 44060412 44063513 44056712 44063313 44063913 44073314 44065613 44058312 44065013 44072114 44072414 44071914 44062613 44065213 44059912 44057312 44059712 44058212 44072814 44060712 44060112 44057812 44058012 44059612 44069114 Serial numbers - OUS: 44055211 44055411 44055711 44056112 44056212 44056412 44056512 44056912 44057112 44057212 44057412 44057512 44057712 44057912 44058512 44058612 44058912 44059012 44059112 44059412 44059512 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44063213 44064013 44064213 44065513 44066313 44066813 44067214 44067414 44067514 44067714 44068114 44068414 44068614 44069214 44069514 44069914 44070014 44070114 44070614 44070714 44071014 44071214 44071314 44071414 44071514 44071714 44071814 44072214 44072314 44072614 44073414 44074014 44074214 44074414 44074714 44074914 44100114 44100614 44101714 44101814 44101914 44102014.

Distribution pattern

Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada.