FDA Device recall Z-1683-2015
Catalys Precision Laser System-Catalys - U - US product
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Catalys Precision Laser System-Catalys - U - US product by Optimedica, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1683-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-20 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Optimedica |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Software version 3.00.05: Serial numbers - US: 44066413 44063113 44065413 44066213 44102714 44060012 44064813…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 4406 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1683-2015%22
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