PASCAL and PASCAL Streamline — Class II medical device recall Z-1774-2013
Terminated recall by Topcon Medical Laser Systems, Inc, reported 2013-07-31. When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed po
| Recall number | Z-1774-2013 |
|---|---|
| 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 | 2012-03-27 |
| Classified | 2013-07-19 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-07-19 |
| Countries outside the US | BR, CN, FR, GB, HK, JP, KR, MY, NL, PK, TH, ZA |
Product
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Reason for recall
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
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-1774-2013. 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.