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Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic
STAAR SURGICAL COMPANY · Model AA4203TL · UDI-DI 00841542100540
MJP
Prescription
0
510(k) clearances
7,587
Adverse events
4
Recalls
19
Facilities
Description
Diopter: 9.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-12 | Johnson & Johnson Surgical Vision, Inc. | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridi |
| 2021-08-06 | Johnson & Johnson Surgical Vision Inc | Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recom |
| 2021-01-27 | Johnson & Johnson Surgical Vision Inc | Due to the release of nonconforming Intraocular Lenses (IOLs). |
| 2020-11-07 | Bausch & Lomb Surgical, Inc. | Product may be missing toric axis marks. |
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