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Monarch
Alcon Laboratories, Inc. · Model 00380659777745 · UDI-DI 00380659777745
10
510(k) clearances
5,360
Adverse events
5
Recalls
41
Facilities
Description
Clareon Monarch IV IOL Delivery System for use with Clareon only
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-17 | Rayner Intraocular Lenses Limited | RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT numbe |
| 2017-09-01 | Aaren Scientific Inc. | The recommended storage temperature on the label is incorrect. |
| 2017-04-05 | Bausch & Lomb Surgical, Inc. | Complaints concerning kinked haptics that were occurring during lens delivery. |
| 2016-09-05 | Alcon Research, Ltd. | The intraocular lens could become lodged within the cartridge |
| 2003-08-18 | Beckman Coulter Inc | Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values. |
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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.