UNKNOWN Adverse Event — Malfunction (MDR 2648035-2020-00397)
UNKNOWN Adverse Event — Malfunction (MDR 2648035-2020-00397) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN; Generic name: UNKNOWN; Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC..
| Device | UNKNOWN |
|---|---|
| Generic name | UNKNOWN |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Report number | 2648035-2020-00397 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | ADDITIONAL INFORMATION: BREAKDOWN OF THE 7 EVENTS ARE AS FOLLOWS: COSMETIC ISSUES ¿ 3, LENS DAMAGE ¿ 1, HAPTIC DAMAGED - 3. SERIAL/LOT NUMBERS OF SUSPECT PRODUCTS: UNKNOWN 7. 2 INVESTIGATIONS WERE COMPLETED, AND 5 INVESTIGATIONS ARE PENDING. NO PRODUCTS RETURNED WERE ANY OF THEM. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFOR |
| Source | openFDA MAUDE (device adverse events) |
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