TECNIS ITEC PRELOADED 1-PIECE IOL Adverse Event — Malfunction (MDR 2648035-2020-00399)
TECNIS ITEC PRELOADED 1-PIECE IOL Adverse Event — Malfunction (MDR 2648035-2020-00399) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TECNIS ITEC PRELOADED 1-PIECE IOL; Generic name: MONOFOCAL IOLS; Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC..
| Device | TECNIS ITEC PRELOADED 1-PIECE IOL |
|---|---|
| Generic name | MONOFOCAL IOLS |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Report number | 2648035-2020-00399 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | A RETROSPECTIVE REVIEW OF VMSR EVENTS WAS CONDUCTED AND SOME DISCREPANCIES WERE NOTED WHICH CORRECTIONS ARE BEING COMPLETED. STATED THERE WERE 55 INVESTIGATIONS COMPLETED. THE CORRECT NUMBER IS 56 WHICH INCLUDES SERIAL# (B)(4). BREAKDOWN OF COMPLETED INVESTIGATION: (B)(4) CARTRIDGE TIP CRACKED/DAMAGED. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT I |
| Source | openFDA MAUDE (device adverse events) |
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