TECNIS Adverse Event — Malfunction (MDR 2648035-2020-00394)
TECNIS Adverse Event — Malfunction (MDR 2648035-2020-00394) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TECNIS; Generic name: MONOFOCAL IOLS; Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC..
| Device | TECNIS |
|---|---|
| Generic name | MONOFOCAL IOLS |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Report number | 2648035-2020-00394 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | ADDITIONAL INFORMATION: BREAKDOWN OF THE 37 EVENTS OF IS AS FOLLOWS: HAPTIC DAMAGED: 30, COSMETIC ISSUES: 1, DAMAGED / BROKEN: 1, FOLDING ISSUES, HAPTIC DAMAGED, LOADING ISSUES: 1, HAPTIC DAMAGED, IOL PARTIALLY DELIVERED, STUCK IN CARTRIDGE: 1, HAPTIC DETACHED: 1, IOL TORN: 1, LENS DAMAGE: 1. SERIAL OR LOT NUMBERS OF SUSPECT PRODUCTS: (B)(4). 21 INVESTIGATIONS WERE COMPLETED AND 16 ARE PENDING FOR |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →