FDA Device recall Z-2405-2016
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system by Topcon Medical Laser Systems, citing topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2405-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-15 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Topcon Medical Laser Systems |
| Distribution | US |
Product
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Reason
Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.
Identifiers
| code_info | Model PASCAL Synthesis (532/577). Serial numbers: United States: 79056215 79064615 77055414 79065715 79088615 7…Model PASCAL Synthesis (532/577). Serial numbers: United States: 79056215 79064615 77055414 79065715 79088615 79088415 79063115 79081015 79095816 79085715 77050213 77050313 77052113 77052913 79088916 79081615 77051913 77052313 77053113 79071415 79073815 77053613 79081515. ROW: 79087915 79073715 79074915 79075415 79075515 79076315 79076515 79076715 79076915 77055714 79050314 79050614 79050714 79050914 79051114 79051214 79051414 79051714 79052114 79052214 79052314 79052714 79052814 79052914 79053014 79053214 79053314 79054014 79054114 79054214 79054414 79054714 79054814 79055014 79055314 79055414 79055715 79057915 79058015 79058115 79058215 79059715 79059815 79064315 79065115 79065215 79065415 79065915 79067515 79067615 79067715 79068015 79068115 79068715 79069915 79070515 79071115 79072415 79072615 79072715 79072815 79072915 79073215 79073315 79073615 79077415 79077915 79078 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2016%22
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