FDA Device recall Z-1515-2015
OptiMedica Catalys Precision Laser System
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of OptiMedica Catalys Precision Laser System by Abbott Medical Optics, citing device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1515-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-20 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Medical Optics |
| Distribution | US |
Product
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Reason
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Identifiers
| code_info | Device Serial No. (U.S.) 44055311 44055611 44055811 44056012 44056312 44056612 44056712 44056812 44057312 440…Device Serial No. (U.S.) 44055311 44055611 44055811 44056012 44056312 44056612 44056712 44056812 44057312 44057812 44058012 44058212 44058312 44059212 44059312 44059612 44059712 44059812 44059912 44060012 44060112 44060312 44060412 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062413 44062613 44062813 44063113 44063313 44063413 44063513 44063613 44063713 44063813 44063913 44064113 44064313 44064413 44064513 44064613 44064713 44064813 44065013 44065113 44065213 44065313 44065413 44065613 44066213 44066413 44066613 44066914 44067014 44068014 44068314 44068914 44069114 44069414 44069814 44070414 44070914 44071914 44072114 44072414 44072714 44072814 44072914 44073014 44073114 44073214 44073314 44073514 44073714 44074114 44074514 44074614 44074814 44100714 44100814 44101014 44101114 44101414 44101614 44102514 44102614 44102714 Device Serial No. (Outside U.S.) |
|---|
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-1515-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.