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UNFOLDER EMERALD

JOHNSON & JOHNSON SURGICAL VISION, INC. · Model EMERALDXL · UDI-DI 15050474534503

KYB Prescription

510(k) clearances

8,619

Adverse events

Recalls

Facilities

Description

MODEL EMERALDXL HANDPIECE, 690735

Recalls

Date	Firm	Reason
2024-11-13	Alcon Research LLC	Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
2016-05-02	Staar Surgical Co.	The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
2009-01-23	Volk Optical Inc	Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged fro
2008-07-07	Alcon Laboratories, Inc	Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
2004-04-21	Staar Surgical Co Inc	Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
2004-02-23	Staar Surgical Co Inc	Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
2004-01-06	Staar Surgical Co Inc	Increased numbers of lens tears during placement of lens into eye.

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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.