TECNIS SYMFONY TORIC Adverse Event — Malfunction (MDR 9614546-2020-00194)
TECNIS SYMFONY TORIC Adverse Event — Malfunction (MDR 9614546-2020-00194) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TECNIS SYMFONY TORIC; Generic name: MULTIFOCAL IOLS; Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC..
| Device | TECNIS SYMFONY TORIC |
|---|---|
| Generic name | MULTIFOCAL IOLS |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Report number | 9614546-2020-00194 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | ADDITIONAL INFORMATION: IT WAS REPORTED THAT SERIAL NUMBER (B)(4) HAPTIC DAMAGED. INVESTIGATION WAS COMPLETED AND IT WAS OBSERVED THAT LENS WAS CUT, HAPTIC DAMAGED, AND HAPTIC DETACHED FOR THIS RETURNED PRODUCT. IN THE INVESTIGATION IT WAS CONCLUDED THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SUR |
| Source | openFDA MAUDE (device adverse events) |
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