MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-27 for RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL) 60005 manufactured by Rxsight, Inc..
| Report Number | 3012712027-2020-00003 |
| MDR Report Key | 9892014 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2019-06-01 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. YI YOUNG |
| Manufacturer Street | 100 COLUMBIA |
| Manufacturer City | ALISO VIEJO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5217954 |
| Manufacturer G1 | RXSIGHT, INC. |
| Manufacturer Street | 100 COLUMBIA |
| Manufacturer City | ALISO VIEJO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL) |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQL |
| Date Received | 2020-03-27 |
| Model Number | 60005 |
| Catalog Number | 60005 |
| Lot Number | L02-001131 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RXSIGHT, INC. |
| Manufacturer Address | 100 COLUMBIA ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |