Home › JOHNSON & JOHNSON SURGICAL VISION, INC. › TECNIS IOL
TECNIS IOL
JOHNSON & JOHNSON SURGICAL VISION, INC. · Model DIU300 · UDI-DI 05050474747876
MJP
Prescription
0
510(k) clearances
7,458
Adverse events
4
Recalls
19
Facilities
Description
TEC EYHANCE TOR II SMPLCTY 27.5D CYL3.00
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.