TECNIS 1-PIECE Adverse Event — Malfunction (MDR 2648035-2020-00395)
TECNIS 1-PIECE Adverse Event — Malfunction (MDR 2648035-2020-00395) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TECNIS 1-PIECE; Generic name: MONOFOCAL IOLS; Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC..
| Device | TECNIS 1-PIECE |
|---|---|
| Generic name | MONOFOCAL IOLS |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Report number | 2648035-2020-00395 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | ADDITIONAL INFORMATION: BREAKDOWN OF 31 EVENTS: COSMETIC ISSUES 23, COSMETIC ISSUES, IOL TORN, LOADING ISSUES, OVERRIDE 1, DELIVERY ISSUE 1, IOL TORN 1, LENS DAMAGED 3, UNSPECIFIED/OTHER W/ PATIENT INVOLVEMENT 1, CARTRIDGE CRACK, STUCK IN CARTRIDGE 1. SERIAL NUMBERS OF SUSPECT PRODUCTS: (B)(4). 28 INVESTIGATIONS WERE COMPLETED, AND 3 INVESTIGATIONS ARE PENDING FROM THIS PERIOD. BREAKDOWN OF 28 COM |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →