Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system — Class II medical device recall Z-2405-2016
Terminated recall by Topcon Medical Laser Systems, Inc, reported 2016-08-17, distributed nationwide. Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This eve
| Recall number | Z-2405-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Topcon Medical Laser Systems, Inc, Santa Clara, CA, United States |
| Recall initiated | 2016-07-15 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2019-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, DZ, FR, GB, GT, HK, IT, JP, MX, NL, NZ, PH, PK, SG, TW |
Product
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2405-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.