MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-20 for DUETTE PROGRESSIVE CN SP76S+0100+025030 SP manufactured by Synergeyes, Inc..
| Report Number | 3005087645-2020-00001 |
| MDR Report Key | 9733982 |
| Report Source | OTHER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DANIELA SOLL |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4449636963 |
| Manufacturer G1 | SYNERGEYES, INC. |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUETTE PROGRESSIVE CN |
| Generic Name | DAILY WEAR HYBRID CONTACT LENS, PRODUCT CODE: HQD |
| Product Code | HQD |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-01-29 |
| Model Number | SP76S+0100+025030 |
| Catalog Number | SP |
| Lot Number | 099318 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES, INC. |
| Manufacturer Address | 2232 RUTHERFORD ROAD CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |