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SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®
INSIGHT INSTRUMENTS, INC. · Model TS-ZR-LS · UDI-DI 00856222004063
HJK
Prescription
1
510(k) clearances
9
Adverse events
3
Recalls
28
Facilities
Description
1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-16 | Vortex Surgical Inc. | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination |
| 2016-02-02 | Volk Optical Inc | The firm discovered that the incorrect lot number was engraved on the product. |
| 2015-02-27 | Volk Optical Inc | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.