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ZEISS Optical Inserts

Carl Zeiss Vision International GmbH · Model 39000032753 · UDI-DI 04064495039415

HQG Prescription
10
510(k) clearances
22
Adverse events
4
Recalls
614
Facilities

Description

ZEISS Optical Inserts

Recalls

DateFirmReason
2020-03-18Frames DirectThe firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resist
2014-09-12Eyemart Express LtdPrescription eyeglass safety lenses did not meet specifications.
2014-02-26Wal Mart Stores, IncFifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.
2010-06-30Luxottica Optical ManufacturingThe polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport g

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Data 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.